Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DSH — Predicate Candidate Screening
195 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
270 days90th percentile
195clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026-07-09 | 170 | 0 |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | 2026-04-23 | 266 | 0 |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | 2025-12-03 | 65 | 0 |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | 2025-08-15 | 262 | 0 |
| K243603 | AeviceMD | Aevice Health Pte. , Ltd. | 2025-05-05 | 165 | 0 |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025-05-02 | 245 | 0 |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | 2024-09-20 | 385 | 0 |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | 2024-02-16 | 66 | 0 |
| K231104 | ABPMpro | Somnomedics GmbH | 2023-11-27 | 222 | 0 |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2023-11-22 | 56 | 0 |
| K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | 2023-09-25 | 245 | 0 |
| K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023-08-30 | 118 | 0 |
| K223382 | AeviceMD | Aevice Health Pte. , Ltd. | 2023-07-07 | 242 | 0 |
| K223049 | CardioSTAT® ECG Test Solution | Icentia, Inc. | 2023-03-22 | 174 | 0 |
| K214073 | eWave Monitor | Wearlinq, Inc. | 2022-10-20 | 297 | 0 |
| K203638 | AT-Patch ECG Analysis System | Atsens Co., Ltd. | 2022-10-12 | 667 | 0 |
| K210179 | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | 2022-08-02 | 557 | 0 |
| K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | 2022-04-27 | 30 | 0 |
| K203168 | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | 2021-07-20 | 270 | 0 |
| K202359 | Zio Monitor | iRhythm Technologies, Inc. | 2021-05-21 | 275 | 0 |
| K201644 | QardioCore | Qardio, Inc. | 2021-02-28 | 256 | 0 |
| K210036 | Carnation Ambulatory Monitor (CAM) | Bardy Diagnostics, Inc. | 2021-02-05 | 30 | 0 |
| K202456 | M5 Recorder | Global Instrumentation, LLC | 2020-12-29 | 124 | 0 |
| K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | 2020-12-20 | 242 | 0 |
| K201040 | Bioflux Software II | Biotricity | 2020-07-29 | 119 | 0 |
| K200870 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2020-05-01 | 30 | 0 |
| K192556 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-10-17 | 30 | 0 |
| K191471 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-08-30 | 88 | 0 |
| K191000 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-05-16 | 30 | 0 |
| K173461 | ECG recorder and Arrhythmia Detector | Smart Solutions Technologies SL | 2018-08-03 | 269 | 0 |
| K172862 | Portable ECG Monitor (ECG3) | Andon Health Co, Ltd. | 2018-07-24 | 307 | 0 |
| K171410 | ePatch | Braemar Manufacturing, LLC | 2018-01-04 | 234 | 0 |
| K171936 | Peerbridge Cor(TM) System | Peerbridge Health, Inc. | 2017-09-27 | 91 | 0 |
| K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, Stealth | Cardiac Insight, Inc. | 2017-03-24 | 198 | 0 |
| K163535 | my Patch sl | Dms-Service, LLC | 2017-02-22 | 68 | 0 |
| K162571 | Bioflux Software | Biotricity, Inc. | 2016-10-13 | 28 | 0 |
| K160704 | myPatch-s | Dms-Service, LLC | 2016-07-15 | 123 | 0 |
| K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software | Cardiac Insight, Inc. | 2015-07-11 | 311 | 0 |
| K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015-06-19 | 190 | 0 |
| K143067 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2014-12-22 | 59 | 0 |
| K131190 | MYPATCH | Dms-Service, LLC | 2013-10-29 | 186 | 0 |
| K130288 | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND | Cardiac Insight, Inc. | 2013-05-29 | 113 | 0 |
| K121319 | ZIO PATCH | iRhythm Technologies, Inc. | 2012-07-18 | 77 | 0 |
| K113862 | ZIO PATCH | iRhythm Technologies, Inc. | 2012-02-06 | 38 | 0 |
| K113176 | MYSENSE HEART | Cardiac Science Corporation | 2011-12-21 | 54 | 0 |
| K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK | Vitalograph (Ireland) , Ltd. | 2011-11-23 | 273 | 0 |
| K111320 | GLOBALCARDIO | Cardiocomm Solutions, Inc. | 2011-10-07 | 150 | 0 |
| K111745 | KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER | Card Guard Scientific Survival , Ltd. | 2011-08-01 | 41 | 0 |
| K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER | Vasomedical, Inc. | 2011-06-28 | 62 | 0 |
| K111096 | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOO | Vasomedical, Inc. | 2011-06-24 | 65 | 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