Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DXQ — Predicate Candidate Screening
199 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
223 days90th percentile
199clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | 2026-06-22 | 173 | 0 |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | 2026-05-06 | 61 | 0 |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS- | Shenzhen Best Electronics Co., Ltd. | 2026-02-13 | 143 | 0 |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | 2026-01-09 | 29 | 0 |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood | Baxter Healthcare Corporation | 2025-12-16 | 193 | 0 |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | 2025-09-03 | 174 | 0 |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neon | Unimed Medical Supplies, Inc. | 2025-07-15 | 103 | 0 |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. | 2024-10-31 | 58 | 0 |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmoma | Wenzhou Longwan Medical Device Factory | 2024-03-20 | 58 | 0 |
| K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023-12-21 | 83 | 0 |
| K232772 | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204 | Shenzhen Plinma Technology Co. , Ltd. | 2023-11-29 | 79 | 0 |
| K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-30 | 58 | 0 |
| K230859 | Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd | 2023-06-28 | 91 | 0 |
| K230145 | ONE-CUF | Ge Medical Systems Information Technologies, Inc. | 2023-03-14 | 55 | 1 |
| K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmo | Cardicare Company, Ltd. | 2022-11-28 | 88 | 0 |
| K222420 | Disposable Blood Pressure Cuff | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-11-21 | 102 | 0 |
| K221857 | Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sp | Zhejiang Lude Technology Development Co., Ltd. | 2022-10-13 | 108 | 0 |
| K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Aut | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-05-18 | 288 | 0 |
| K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stet | Shanghai Caremate Medical Device Co., Ltd. | 2021-10-19 | 190 | 0 |
| K211747 | Reusable NIBP Cuff | Shenzhen Coreray Technology Co., Ltd. | 2021-09-23 | 108 | 0 |
| K203620 | Aneroid Sphygmomanometer | Wuxi Exanovo Medical Instrument Co., Ltd. | 2021-03-23 | 102 | 0 |
| K203652 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, | Jkh USA, LLC | 2021-01-06 | 23 | 0 |
| K193259 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmoma | Little Doctor Electronic (Nantong)Co.,Ltd | 2020-07-02 | 219 | 0 |
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmoma | Honsun (Nantong) Co., Ltd. | 2020-04-06 | 207 | 0 |
| K193629 | Disposable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-25 | 90 | 0 |
| K191253 | Reusable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-09-17 | 131 | 0 |
| K191209 | Aneroid Type Blood Pressure Kit | Dongguan Mars Medical Products Co., Ltd. | 2019-06-18 | 43 | 0 |
| K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood | Wenzhou Renhua Instruments Co., Ltd. | 2019-05-22 | 44 | 0 |
| K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-17 | 102 | 0 |
| K173197 | Reusable NIBP Cuff | Orantech, Inc. | 2018-08-21 | 323 | 0 |
| K173869 | Med-link Reusable Blood Pressure Cuff | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2018-08-02 | 225 | 0 |
| K173246 | ANEROID SPHYGMOMANOMETER | Wenzhou Bokang Instruments Co., Ltd. | 2018-05-30 | 236 | 0 |
| K180335 | Accutension Smartphone Auscultatory Blood | Shanghai Hulu Devices Co., Ltd. | 2018-03-08 | 30 | 0 |
| K171889 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2017-12-19 | 176 | 0 |
| K173044 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Ningbo Albert Novosino Co., Ltd. | 2017-11-20 | 53 | 0 |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable B | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2016-11-28 | 277 | 0 |
| K161035 | Medline Singe Patient Use Blood Pressure Cuff | Medline Industries, Inc. | 2016-06-13 | 61 | 0 |
| K152006 | Cogent Hemodynamic Monitoring System | Icu Medical, Inc. | 2016-05-05 | 289 | 0 |
| K153251 | Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff | Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. | 2016-04-14 | 156 | 0 |
| K151810 | Bpump Blood Pressure Cuff | Shenzhen Pump Medical System Co., Ltd. | 2015-12-17 | 168 | 0 |
| K152465 | Disposable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 | 59 | 0 |
| K152468 | Reusable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 | 59 | 0 |
| K152801 | ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS AB | Statcorp Medical | 2015-10-27 | 29 | 0 |
| K152363 | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra | Philips Medical Systems | 2015-10-27 | 68 | 0 |
| K151246 | Aneroid Sphygmomanometer | Jiaxing Zhongfa Medical Products Co., Ltd. | 2015-06-30 | 50 | 0 |
| K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | 2015-06-30 | 46 | 0 |
| K143728 | Minhua Disposable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus | 2015-05-15 | 137 | 0 |
| K143332 | Fast Sphyg by Koven | Koven Technology, Inc. | 2015-04-14 | 145 | 0 |
| K150227 | Disposable Blood Pressure Cuff Guard | Pinhu Sama Medical Packing Co., Ltd. | 2015-04-02 | 59 | 0 |
| K141998 | SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS | Pinghu Sama Medical Packing Co., Ltd. | 2014-09-19 | 58 | 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