Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXN — Predicate Candidate Screening
1,219 FDA 510(k) clearances under this product code; the 50 most recent screened below.
110 daysmedian FDA review time
271 days90th percentile
1,219clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | 2026-07-23 | 113 | 0 |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | 2026-07-23 | 107 | 0 |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-18 | 266 | 0 |
| K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | 2026-06-16 | 105 | 0 |
| K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | 2026-06-15 | 266 | 0 |
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 | 251 | 0 |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 | 184 | 0 |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 | 148 | 0 |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP100 | Biozen, LLC | 2026-05-06 | 222 | 0 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD | Honsun (Nantong) Co., Ltd. | 2026-04-28 | 90 | 0 |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP | Joytech Healthcare Co. , Ltd. | 2026-04-28 | 263 | 0 |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 | 130 | 0 |
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-H | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 | 62 | 0 |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 | 93 | 0 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series mod | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 | 56 | 0 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 | 184 | 0 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 | 147 | 0 |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 | 141 | 0 |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 | 266 | 0 |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP | Joytech Healthcare Co. , Ltd. | 2026-02-13 | 171 | 0 |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-01-12 | 259 | 0 |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,R | Ningbo Ranor Medical Technology Co., Ltd. | 2026-01-09 | 106 | 0 |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2025-12-19 | 249 | 0 |
| K251331 | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | 2025-10-27 | 180 | 0 |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-7 | Honsun (Nantong) Co., Ltd. | 2025-10-09 | 119 | 0 |
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP | Shenzhen Finicare Co., Ltd. | 2025-10-02 | 30 | 0 |
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X | Dongguan E-Test Technology Co., Ltd. | 2025-09-03 | 219 | 0 |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Corporation | 2025-08-06 | 117 | 0 |
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHe | Andon Health Co, Ltd. | 2025-08-04 | 115 | 0 |
| K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | 2025-07-30 | 216 | 0 |
| K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606 | Cemho Medical Technology (Guangdong) Co., Ltd. | 2025-07-16 | 96 | 0 |
| K250185 | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, | Jiangxi Aicare Medical Technology Co., Ltd. | 2025-07-14 | 173 | 0 |
| K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025-07-02 | 139 | 0 |
| K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DB | Joytech Healthcare Co. , Ltd. | 2025-06-26 | 121 | 0 |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-05-02 | 101 | 0 |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Mon | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-30 | 125 | 0 |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Mon | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-24 | 98 | 0 |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. | 2025-04-08 | 81 | 0 |
| K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | 2025-03-14 | 59 | 0 |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (mo | Shenzhen Urion Technology Co., Ltd. | 2025-02-21 | 144 | 0 |
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315 | Shenzhen Bsx Technology Electronics Co., Ltd. | 2025-02-19 | 261 | 0 |
| K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-11 | 250 | 0 |
| K243661 | Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. | 2025-02-07 | 72 | 0 |
| K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. | 2025-02-05 | 181 | 0 |
| K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-03 | 245 | 0 |
| K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | 2025-01-30 | 154 | 0 |
| K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station | Murata Vios, Inc. | 2025-01-23 | 223 | 0 |
| K241066 | BB-613-BPM | Biobeat Technologies , Ltd. | 2025-01-14 | 271 | 0 |
| K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP | Joytech Healthcare Co. , Ltd. | 2025-01-13 | 237 | 0 |
| K242528 | Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK2 | Shenzhen Ruiankang Technology Co., Ltd. | 2025-01-10 | 137 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda