Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DSI — Predicate Candidate Screening
398 FDA 510(k) clearances under this product code; the 50 most recent screened below.
117 daysmedian FDA review time
314 days90th percentile
398clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 | 452 | 0 |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection S | Infobionic, Inc. | 2025-07-29 | 172 | 0 |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-30 | 281 | 0 |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection S | Infobionic, Inc. | 2023-10-06 | 248 | 0 |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023-08-30 | 120 | 0 |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | 2020-04-09 | 153 | 0 |
| K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | 2020-03-26 | 181 | 0 |
| K190574 | Patient Assistant Model PA97000 | Medtronic, Inc. | 2019-09-24 | 202 | 0 |
| K182532 | Liba3 System | National Cardiac, Inc. | 2019-05-15 | 243 | 0 |
| K181658 | MobileECG 2 BT | Memtec Corporation | 2019-03-26 | 274 | 0 |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | 2018-07-11 | 194 | 0 |
| K173170 | Epicardia Anywhere | Medicomp, Inc. | 2018-01-10 | 103 | 0 |
| K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | 2016-07-22 | 233 | 0 |
| K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | 2016-05-25 | 175 | 0 |
| K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | 2016-04-22 | 214 | 0 |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016-04-08 | 238 | 0 |
| K151835 | Vital Signs Patch System | Lifewatch Technologies , Ltd. | 2016-02-05 | 214 | 0 |
| K151269 | ECG Mini System Continuous ECG Monitor and Arrhythmia Detect | Lifewatch Technologies , Ltd. | 2016-01-15 | 247 | 0 |
| K152491 | MoMe Software Platform | Infobionic, Inc. | 2015-12-17 | 107 | 0 |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | Medicalgorithmics S.A. | 2015-10-08 | 30 | 0 |
| K151188 | BodyGuardian Remote Monitoring System | Preventice | 2015-09-17 | 136 | 0 |
| K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detecto | Lifewatch Technologies , Ltd. | 2015-09-11 | 291 | 0 |
| K151681 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 | 25 | 7 |
| K150117 | Medtronic Patient Asistant | Medtronic, Inc. | 2015-05-27 | 127 | 0 |
| K150310 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-05-13 | 93 | 6 |
| K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015-03-12 | 202 | 0 |
| K141441 | MENNTOR X7 | Mennen Medical , Ltd. | 2015-01-09 | 221 | 0 |
| K132407 | VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) | Lifewatch Technologies , Ltd. | 2014-12-19 | 504 | 0 |
| K142180 | TELESENSE | Scottcare Corporation | 2014-12-12 | 126 | 0 |
| K140548 | CORCAM HEART MONITOR | Corcam Technologia, SA | 2014-05-23 | 80 | 0 |
| K131000 | V-PATCH SYSTEM | Intelesens Limited | 2014-01-08 | 273 | 0 |
| K124060 | MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | Medicalgorithmics S.A. | 2013-02-21 | 52 | 0 |
| K121197 | BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN C | Preventice, Inc. | 2012-08-10 | 113 | 0 |
| K112921 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | Medicalgorithmics S.A. | 2012-05-16 | 226 | 0 |
| K120774 | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORI | Welch Allyn, Inc. | 2012-04-10 | 27 | 0 |
| K113125 | INTELLIVUE MX40 PATIENT MONITOR | Philips Medical Systems | 2011-11-17 | 24 | 2 |
| K111160 | INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY | Intricon Datrix Corporation | 2011-08-01 | 98 | 0 |
| K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR | Tz Medical, Inc. | 2011-06-13 | 285 | 0 |
| K103764 | REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL | Medtronic, Inc. | 2011-05-04 | 132 | 0 |
| K110499 | CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTO | Card Guard Scientific Survival , Ltd. | 2011-04-06 | 43 | 2 |
| K103142 | SPACELABS MULTI-PARAMETER MODULE | Spacelabs Healthcare, Inc. | 2011-03-03 | 129 | 14 |
| K102111 | MEDICAL MAGNETIC TAPE RECORDER | Wpr Medical AS | 2010-12-07 | 132 | 0 |
| K101703 | MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND A | Card Guard Scientific Survival , Ltd. | 2010-07-13 | 26 | 0 |
| K101639 | CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2010-06-25 | 15 | 2 |
| K093766 | VITALOGIK 6000/6500 | Mennen Medical , Ltd. | 2010-05-07 | 151 | 0 |
| K100155 | TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM | Biomedical Systems Corp. | 2010-04-20 | 90 | 0 |
| K092947 | TELESENTRY, MODEL TS01 | Scottcare Corporation | 2010-02-26 | 155 | 1 |
| K091927 | INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-11-03 | 126 | 0 |
| K091971 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIA | Corventis, Inc. | 2009-08-27 | 57 | 0 |
| K090037 | MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETEC | Medicalgorithmics SP Z.O.O. | 2009-05-22 | 136 | 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