Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MWJ — Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
268 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCAR | Seers Technology Co., Ltd. | 2026-06-25 | 268 | 0 |
| K252839 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | 2026-06-18 | 286 | 0 |
| K231424 | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | 2024-12-13 | 576 | 0 |
| K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | 2024-05-07 | 153 | 0 |
| K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | 2022-11-07 | 469 | 1 |
| K222017 | Biotres | Biotricity | 2022-07-28 | 20 | 0 |
| K210758 | Q Patch | Medicalgorithmics S.A. | 2022-06-02 | 444 | 0 |
| K211709 | Biotres | Biotricity | 2022-01-19 | 230 | 0 |
| K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | 2021-11-22 | 178 | 1 |
| K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | 2018-06-08 | 252 | 0 |
| K161062 | NR Recorder | Norav Medical GmbH | 2016-06-13 | 59 | 0 |
| K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | 2016-02-26 | 164 | 0 |
| K142424 | DR300 HOLTER MONITOR | North East Monitoring, Inc. | 2014-11-25 | 88 | 0 |
| K133014 | DMS 300-2W HOLTER ECG RECORDER | Diagnostic Monitoring Software | 2014-05-19 | 236 | 0 |
| K130294 | BRAEMAR CARDIOKEY HOLTER RECORDER | Braemar Manufacturing, LLC | 2013-10-16 | 252 | 0 |
| K130785 | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | 2013-07-26 | 127 | 0 |
| K122272 | CARDIOMEM | Getemed Medizin- Und Informationstechnik AG | 2013-03-28 | 241 | 0 |
| K112573 | EZSLEEP SLEEP QUALITY RECORDER | Platinum Team Co., Ltd. | 2012-03-22 | 198 | 0 |
| K112601 | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | Intricon Datrix Corporation | 2011-11-09 | 63 | 0 |
| K101969 | MH1 MICROHOLTER RECORDER | Exelys, LLC | 2011-02-04 | 206 | 0 |
| K101024 | KENZ CARDY302 MAX | Suzuken Co., Ltd. | 2011-01-06 | 268 | 0 |
| K102723 | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | Memtec Corp. | 2010-12-09 | 79 | 0 |
| K100310 | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT | BTL Industries, Inc. | 2010-10-13 | 252 | 0 |
| K100266 | ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CA | Camntech, Ltd. | 2010-04-29 | 90 | 0 |
| K083382 | CHROMA, MODEL: RZ153C | Scottcare Corporation | 2009-08-13 | 272 | 0 |
| K091054 | WALK400H | Et Medical Devices Spa | 2009-07-27 | 105 | 0 |
| K073545 | AUDICOR, HEMO AMBULATORY MONITOR | Inovise Medical, Inc. | 2008-09-09 | 266 | 0 |
| K071085 | E3-80 PORTABLE ECG RECORDER & ANALYZER | Micro-Star International Co., Ltd. | 2007-10-03 | 169 | 0 |
| K071733 | DL900 SERIES HOLTER RECORDER | Braemar, Inc. | 2007-07-24 | 28 | 0 |
| K063042 | CARDIOMEM CM 3000-12BT | Getemed Medizin- Und Informationstechnik AG | 2007-05-30 | 239 | 0 |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | North East Monitoring, Inc. | 2007-05-25 | 142 | 0 |
| K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG | Braemar, Inc. | 2007-04-27 | 17 | 0 |
| K062959 | DMS 300-2, 300-3 AND 300-4 | Diagnostic Monitoring Software | 2006-10-16 | 17 | 0 |
| K061293 | TELAHEART DIGITAL RECORDER | North East Monitoring, Inc. | 2006-08-25 | 108 | 0 |
| K051686 | CARDIOMEM CM 3000-12 | Getemed Medizin- Und Informationstechnik AG | 2005-07-14 | 21 | 0 |
| K050731 | SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM | Ge Medical Systems Information Technologies | 2005-05-19 | 59 | 0 |
| K043010 | HOLTER RECORDER H3+ | Mortara Instrument, Inc. | 2005-02-25 | 116 | 0 |
| K042469 | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER | Braemar, Inc. | 2004-10-06 | 23 | 0 |
| K041901 | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | North East Monitoring, Inc. | 2004-08-31 | 48 | 0 |
| K032882 | RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONIT | Recom Managed Systems, Inc. | 2004-01-28 | 135 | 0 |
| K031074 | DIGITAL AMBULATORY ECG (HOLTER) RECORDER | Datrix | 2003-10-15 | 194 | 0 |
| K032276 | CLICK HOLTER | Remco Italia S.P.A. | 2003-08-27 | 35 | 0 |
| K032466 | SPIDERVIEW | Ela Medical, Inc. | 2003-08-22 | 11 | 0 |
| K030856 | ER800 SERIES ECG EVENT RECORDER | Braemar Corp. | 2003-03-28 | 10 | 0 |
| K021470 | SEER LIGHT COMPACT DIGITAL HOLTER RECORDER | General Electric Medical Systems Information Techn | 2002-11-14 | 190 | 0 |
| K021373 | H12+HOLTER RECORDER | Mortara Instrument, Inc. | 2002-06-27 | 57 | 0 |
| K011837 | LIFECARD CF 7 DAY | Reynolds Medical , Ltd. | 2001-07-13 | 31 | 0 |
| K003707 | CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A | Cardionet | 2001-05-16 | 166 | 0 |
| K003520 | NEXAN SYSTEM, MODEL NX-300 | Nexan, Ltd. | 2000-12-13 | 28 | 0 |
| K001349 | CARDIOVISE ECG INTERPRETATIVE SOFTWARE | Inovise Medical, Inc. | 2000-07-27 | 90 | 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