Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DXH — Predicate Candidate Screening
297 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
314 days90th percentile
297clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026-02-13 | 382 | 0 |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | 2025-12-08 | 314 | 0 |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | 2025-12-05 | 394 | 0 |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025-11-18 | 330 | 0 |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | 2025-06-17 | 264 | 0 |
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | 2023-12-06 | 35 | 0 |
| K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | 2022-10-20 | 30 | 0 |
| K220795 | QT ECG | QT Medical, Inc. | 2022-09-26 | 192 | 0 |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch | Verily Life Sciences, LLC | 2022-07-19 | 280 | 0 |
| K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022-05-25 | 107 | 0 |
| K211668 | KardiaMobile Card | AliveCor, Inc. | 2021-11-30 | 182 | 0 |
| K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021-09-22 | 72 | 0 |
| K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021-06-30 | 107 | 0 |
| K201669 | SimpleSENSE | Nanowear, Inc. | 2020-11-06 | 140 | 0 |
| K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | 2020-10-30 | 338 | 0 |
| K201208 | Halo AF Detection System | Livmor | 2020-09-23 | 141 | 0 |
| K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2020-01-24 | 241 | 0 |
| K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2020-01-17 | 135 | 0 |
| K183319 | Triangle System | AliveCor, Inc. | 2019-05-10 | 161 | 0 |
| K182396 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2019-04-12 | 220 | 0 |
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | Cardiocomm Solutions, Inc. | 2019-02-22 | 281 | 0 |
| K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2019-02-16 | 47 | 0 |
| K182040 | Coala Heart Monitor | Coala Life AB | 2019-02-08 | 193 | 0 |
| K182456 | Study Watch | Verily Life Sciences, LLC | 2019-01-17 | 132 | 0 |
| K173589 | Prizma | G-Medical Innovations , Ltd. | 2018-11-30 | 375 | 0 |
| K173872 | FibriCheck | Qompium NV | 2018-09-28 | 282 | 0 |
| K173248 | CARDIOSKIN | Bioserenity Sas | 2018-08-11 | 305 | 0 |
| K180157 | QT ECG | QT Medical, Inc. | 2018-05-04 | 105 | 0 |
| K172311 | BioFlux Device | Biotricity, Inc. | 2017-12-15 | 136 | 0 |
| K171816 | Kardia Band System | AliveCor, Inc. | 2017-11-16 | 150 | 0 |
| K172801 | ECG SENTINEL System | Cardiomedix, Inc. | 2017-10-18 | 30 | 0 |
| K170506 | ECG Check - Universal, ECG Check - Universal Plus | Cardiac Designs, Inc. | 2017-10-02 | 223 | 0 |
| K170181 | Prizma | G-Medical Innovations , Ltd. | 2017-09-01 | 225 | 0 |
| K161431 | SimplECG | Nanowear, Inc. | 2016-11-30 | 190 | 0 |
| K151013 | Vitaphone Tele ECG Loop Recorder | Vitasystems GmbH | 2015-04-30 | 15 | 0 |
| K143032 | eMotion Faros ECG Mobile | Mega Electronics , Ltd. | 2015-03-29 | 158 | 0 |
| K142476 | Master Caution Device MCD | Healthwatch , Ltd. | 2015-02-17 | 167 | 0 |
| K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015-01-27 | 125 | 0 |
| K142672 | AliveCor Heart Monitor | AliveCor, Inc. | 2014-12-03 | 75 | 0 |
| K133703 | PHYSIOGLOVE ET SYSTEM | Commwell R&D , Ltd. | 2014-08-18 | 258 | 0 |
| K140933 | ALIVECOR HEART MONITOR | AliveCor, Inc. | 2014-08-15 | 126 | 1 |
| K141813 | RHYTHMSTAR SYSTEM | RhythMedix, LLC | 2014-08-05 | 29 | 0 |
| K130878 | CLOUDEKG | Makromed, Inc. | 2014-04-04 | 371 | 0 |
| K132206 | MELYS ATRIAL FIBRILLATION SCREENING MONITOR | Advanced Fluidics, LLC | 2014-03-19 | 246 | 0 |
| K131699 | EMOTION ECG MOBILE | Mega Electronics , Ltd. | 2013-11-26 | 168 | 0 |
| K121628 | EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013-06-25 | 386 | 0 |
| K122184 | ECG CHECK | Cardiac Designs, LLC | 2013-02-14 | 206 | 0 |
| K113514 | SMARTHEART | Shl Telemedicine International , Ltd. | 2012-02-22 | 86 | 0 |
| K100383 | VITAPHONE. MODEL 100 BT | Vitasystems GmbH | 2010-04-20 | 63 | 0 |
| K093976 | RAISIN PERSONAL MONITOR | Proteus Biomedical, Inc. | 2010-03-25 | 91 | 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