Atlas FDA

DXN

1,219 FDA 510(k) clearances · Product code

110 daysmedian time to decision
271 days90th percentile
1,219clearances measured

FDA profile

Official device name
System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 162 · 2022: 155 · 2023: 162 · 2024: 270 · 2025: 245 · 2026: 711
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) (K261082)Microlife Corporation2026-07-23
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) (K261136)Guangzhou Daxin Health Technology Co., Ltd.2026-07-23
Wrist Blood Pressure Monitor (XW-05) (K253126)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-18
VicorderCS (VCS-SYS-1100) (K260693)80 Beats Medical GmbH2026-06-16
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) (K253059)Tournicare Pty, Ltd.2026-06-15
Upper arm electronic blood pressure monitor (XB-01) (K253124)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-03
Blood Pressure Monitor (W06LT) (K253570)Shenzhen Jamr Technology Co., Ltd.2026-05-20
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) (K254048)Shenzhen Urion Technology Co., Ltd.2026-05-14
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) (K253152)Biozen, LLC2026-05-06
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) (K260260)Honsun (Nantong) Co., Ltd.2026-04-28
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) (K252501)Joytech Healthcare Co. , Ltd.2026-04-28
Korotkoff sound blood pressure monitor (K253982)Beijing Hanvon Health Technology Co., Ltd.2026-04-21
Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro (K260276)Shenzhen AOJ Medical Technology Co., Ltd.2026-04-01
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) (K254225)Shenzhen HanHan Technology Co., Ltd.2026-04-01
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (K260273)Shenzhen Urion Technology Co., Ltd.2026-03-26
YUWELL® Electronic Blood Pressure Monitor (YE630CR) (K252779)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-03-05
YUWELL® Electronic Blood Pressure Monitor (YE650AR) (K253228)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-23
Wrist Blood Pressure Monitor (BPM-W1VL) (K253133)Shenzhen Imdk Medical Technology Co., Ltd.2026-02-13
Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (K251581)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-02-13
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (K252685)Joytech Healthcare Co. , Ltd.2026-02-13
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (K251307)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-01-12
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (K253142)Ningbo Ranor Medical Technology Co., Ltd.2026-01-09
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (K251143)Ningbo Ranor Medical Science & Technology Co., Ltd.2025-12-19
Blood Pressure Monitor (B73, BE23T) (K251331)Shenzhen Jamr Technology Co., Ltd.2025-10-27
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (K251795)Honsun (Nantong) Co., Ltd.2025-10-09
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) (K252769)Shenzhen Finicare Co., Ltd.2025-10-02
Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) (K250231)Dongguan E-Test Technology Co., Ltd.2025-09-03
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) (K251120)Microlife Corporation2025-08-06
iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr (K251113)Andon Health Co, Ltd.2025-08-04
ArteVu (K244007)Cardio Ring Technologies, Inc. Taiwan Branch2025-07-30
Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) (K251102)Cemho Medical Technology (Guangdong) Co., Ltd.2025-07-16
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) (K250185)Jiangxi Aicare Medical Technology Co., Ltd.2025-07-14
G0 Blood Pressure Monitoring System (G0) (K250415)Aktiia SA2025-07-02
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (K250548)Joytech Healthcare Co. , Ltd.2025-06-26
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (K250161)Shenzhen AOJ Medical Technology Co., Ltd.2025-05-02
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); (K244000)Shenzhen AOJ Medical Technology Co., Ltd.2025-04-30
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) (K250116)Shenzhen AOJ Medical Technology Co., Ltd.2025-04-24
Globalcare Blood Pressure Monitor (GUS610) (K250136)Globalcare Medical Technology Co., Ltd.2025-04-08
KOROT Blood Pressure Monitor (KOROT P3 Accurate) (K250091)Korot Co., Ltd.2025-03-14
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) (K243115)Shenzhen Urion Technology Co., Ltd.2025-02-21
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) (K241578)Shenzhen Bsx Technology Electronics Co., Ltd.2025-02-19
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) (K241634)Guangdong Xinyu Electronic and Technology Co., Ltd.2025-02-11
Electronic Blood Pressure Monitor (K243661)Hetaida Technology Co., Ltd.2025-02-07
Accurate Mini Non-invasive blood pressure monitor (AMB-001) (K242352)Accurate Meditech, Inc.2025-02-05
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (K241590)Guangdong Xinyu Electronic and Technology Co., Ltd.2025-02-03
Wrist Blood Pressure Monitor (OHMS11, OHMS12) (K242568)Shenzhen Zhongkemingwang Telecommunications Software Corp.2025-01-30
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (K241728)Murata Vios, Inc.2025-01-23
BB-613-BPM (K241066)Biobeat Technologies , Ltd.2025-01-14
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) (K241431)Joytech Healthcare Co. , Ltd.2025-01-13
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) (K242528)Shenzhen Ruiankang Technology Co., Ltd.2025-01-10
Arm Blood Pressure Monitor (model: BPM-A7VL) (K243118)Shenzhen Imdk Medical Technology Co., Ltd.2024-11-26
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (K241007)Shenzhen Urion Technology Co., Ltd.2024-10-24
Arm Type Blood Pressure Monitor (BPM82) (K242193)Avita Corporation2024-10-22
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) (K241613)Shenzhen Hbcare Technology Co.,Ltd2024-10-16
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) (K242721)Shenzhen Finicare Co., Ltd.2024-10-04
Blood Pressure Monitor (TMB-2092-G) (K241351)Guangdong Transtek Medical Electronics Co., Ltd.2024-08-21
Upper Arm Electronic Blood Pressure Monitor (K241129)Shenzhen Goodlymed Technology Co., Ltd.2024-07-03
Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) (K240729)Shenzhen Pango Medical Electronics Co., Ltd.2024-06-14
Blood Pressure Monitor (BBZ32-AA01) (K240832)Guangdong Transtek Medical Electronics Co., Ltd.2024-06-07
Blood Pressure Monitor (TMB-2296-BT) (K240254)Guangdong Transtek Medical Electronics Co., Ltd.2024-05-31
Blood Pressure Monitor (TMB-2287-B) (K240102)Guangdong Transtek Medical Electronics Co., Ltd.2024-04-29
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) (K234041)Andon Health Co, Ltd.2024-04-22
Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) (K231984)Shenzhen Hingmed Medical Instrument Co., Ltd.2024-03-26
Blood Pressure Monitor (K233146)Shenzhen Jamr Technology Co., Ltd.2024-03-19
Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) (K233799)Shenzhen Yuezhongxing Technology Co., Ltd.2024-03-15
Arm-type Fully Automatic Digital Blood Pressure Monitor (K231303)Joytech Healthcare Co. , Ltd.2024-01-26
Pursuant Health Kiosk (G1.D5) (K230996)Pursuant Health2024-01-04
Blood Pressure Monitor (K233130)Guangdong Transtek Medical Electronics Co., Ltd.2023-12-20
Digital Blood Pressure Monitor (Model: YB-800) (K231478)Wenzhou Yosun Medical Technology Co.,Ltd2023-12-15
Wrist Blood Pressure Monitor (K232815)Zhuhai Yueja Medical Device Technology Co., Ltd.2023-12-11
SimpleSense-BP, SimpleSense-BP Software Application (K232053)Nanowear, Inc.2023-12-08
Electronic Blood Pressure Monitor (K232814)Zhuhai Yueja Medical Device Technology Co., Ltd.2023-12-05
Electronic Blood Pressure Monitor, model: HTD6602US (K223170)Hetaida Technology Co., Ltd.2023-12-05
Digital Blood Pressure Monitor (K231250)Guangdong Genial Technology Co., Ltd.2023-11-28
Blood Pressure Monitor (K232713)Guangdong Transtek Medical Electronics Co., Ltd.2023-11-28
Blood pressure monitor (K232621)Guangdong Transtek Medical Electronics Co., Ltd.2023-11-22
Digital Blood Pressure Monitor (Arm Type) (K231245)Guangdong Genial Technology Co., Ltd.2023-11-22
Electronic Blood Pressure Monitor (K231310)Shenzhen Jumper Medical Equipment Co., Ltd.2023-10-27
Acumen IQ finger cuff (K230919)Edwards Lifesciences, LLC2023-10-24
Arm Blood Pressure Monitor (K231050)Alicn Medical Shenzhen, Inc.2023-10-11
Boppli Infant Blood Pressure Monitor (K223873)Pyrames, Inc.2023-09-29
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) (K231367)Shenzhen Finicare Co., Ltd.2023-09-18
Arm Blood Pressure Monitor (K230649)Alicn Medical Shenzhen, Inc.2023-09-07
Digital Blood Pressure Monitor WBP Series (K231542)Weony (Shenzhen) Technology Co., Ltd.2023-09-07
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (K230566)Joytech Healthcare Co. , Ltd.2023-08-25
Wrist Type Blood Pressure Monitor (W05,W1101L) (K230409)Shenzhen Jamr Technology Co., Ltd.2023-08-25
Electronic Blood Pressure Monitor (K230642)Dongguan Kangweile Electronic Technology Co., Ltd.2023-08-11
BPBIO750 (K231174)Inbody Co., Ltd.2023-08-02
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B (K222994)Shenzhen AOJ Medical Technology Co., Ltd.2023-07-26
Blood Pressure Monitor (K223374)Guangdong Transtek Medical Electronics Co., Ltd.2023-06-30
Upper Arm Blood Pressure Monitor (K230176)Shenzhen Yolanda Technology Co., Ltd.2023-06-29
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K (K230075)Microlife Intellectual Property GmbH2023-06-28
Accurate 24 Non-invasive blood pressure monitor (K222658)Accurate Meditech, Inc.2023-06-21
Electronic Blood Pressure Monitor (K223291)Shenzhen Pango Medical Electronics Co., Ltd.2023-06-14
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (K222979)Microlife Intellectual Property GmbH2023-05-19
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 (K222926)Shenzhen Yuezhongxing Technology Co., Ltd.2023-05-05
CONNEQT PULSE (K221742)Atcor Medical2023-04-21
Task Force CORE (K223332)Cnsystems Medizintechnik GmbH2023-04-12
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (K222887)Famidoc Technology Company Limited2023-04-10
Electronic Sphygmomanometers (K222394)Qingdao Yasee Medical Device Co., Ltd.2023-03-03
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Every clearance here is in the API, with alerts when new ones post.