Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QYX — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
333 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250793 | RhythmStar System (SL) | RhythMedix, LLC | 2026-04-21 | 403 | 0 |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. | 2025-07-11 | 438 | 0 |
| K240653 | SmartCardia 7L Platform (MCT) | Smartcardia SA | 2024-10-31 | 238 | 0 |
| K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-21 | 291 | 0 |
| K233584 | RhythmStar System | RhythMedix, LLC | 2024-07-08 | 244 | 0 |
| K162956 | NOWCARDIO SYSTEM | Contex International Technologies (Canada), Inc. | 2017-09-22 | 333 | 0 |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L | Lifewatch Services, Inc. | 2017-08-01 | 155 | 0 |
| K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017-06-02 | 169 | 1 |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection | Infobionic, Inc. | 2016-03-11 | 58 | 0 |
| K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | Infobionic, Inc. | 2014-09-19 | 284 | 0 |
| K133701 | NUVANT MCT SYSTEM | Corventis, Inc. | 2014-02-06 | 65 | 0 |
| K113372 | NUVANT, MOBILC CARDIAC TELEMETRY | Corventis, Inc. | 2012-03-07 | 112 | 0 |
| K111917 | NUVANT, MOBILE CARDIAC TELEMETRY | Corventis, Inc. | 2011-08-24 | 49 | 0 |
| K103706 | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR | Applied Cardiac Systems, Inc. | 2011-08-24 | 247 | 0 |
| K093288 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION | Cardionet, Inc. | 2010-04-08 | 170 | 0 |
| K090696 | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIA | Corventis, Inc. | 2009-06-19 | 95 | 0 |
| K072558 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2007-12-05 | 85 | 0 |
| K063222 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2006-11-14 | 21 | 0 |
| K052240 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2005-10-19 | 63 | 0 |
| K020632 | ENGUARD REMOTE PATIENT MONITOR | Mennen Medical , Ltd. | 2002-03-15 | 16 | 0 |
| K982803 | HEARTLINK, MODEL II | Cardiac Telecom Corp. | 1998-11-13 | 95 | 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