Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MLO — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
186 daysmedian FDA review time
296 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | 2025-03-21 | 266 | 0 |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | 2024-11-08 | 231 | 0 |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2020-09-02 | 156 | 0 |
| K193177 | CER-S | Cardiocalm | 2020-08-26 | 282 | 0 |
| K182030 | Faros Mobile | Bittium Biosignals , Ltd. | 2018-11-08 | 101 | 0 |
| K140847 | CARDIOSPY ECG HOLTER SYSTEMS | Labtech Kft. | 2014-12-05 | 246 | 0 |
| K131897 | CV3000 HOLTER ANALYSIS SYSTEM | Vales & Hills Biomedical Tech. , Ltd. | 2013-11-26 | 154 | 0 |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Inovise Medical, Inc. | 2013-10-11 | 213 | 0 |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WI | Inovise Medical, Inc. | 2012-09-20 | 218 | 0 |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | Norav Medical Corp. | 2011-11-10 | 163 | 0 |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Inovise Medical, Inc. | 2011-10-24 | 238 | 0 |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | Contec Medical System Co., Ltd. | 2011-09-30 | 512 | 0 |
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3S | Galix Biomedical Instrumentation, Inc. | 2010-07-09 | 296 | 0 |
| K063339 | MEDICK MHM200 PERSONAL HEART MONITOR | Medick Healthcare , Ltd. | 2007-06-29 | 235 | 0 |
| K062088 | PREMIER 11 HOLTER | Diagnostic Monitoring Software | 2006-08-25 | 32 | 0 |
| K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | Global Instrumentation, LLC | 2005-09-26 | 91 | 0 |
| K042782 | SEER MC | Ge Medical Systems Information Technologies | 2005-09-02 | 331 | 0 |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Medicomp, Inc. | 2005-03-24 | 99 | 0 |
| K042108 | VISTA PLUS | Novacor | 2005-01-19 | 168 | 0 |
| K040753 | R-TEST EVOLUTION 3 | Novacor | 2004-06-10 | 78 | 0 |
| K024323 | CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AN | Biomedical Systems Corp. | 2003-06-30 | 186 | 0 |
| K031466 | IQMARK DIGITAL HOLTER | Brentwood Medical Technology Corp. | 2003-06-11 | 34 | 0 |
| K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | Norav Medical , Ltd. | 2002-05-08 | 267 | 0 |
| K010396 | C. NET 2100 | Cardionetics, Ltd. | 2001-10-04 | 237 | 0 |
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-09-28 | 183 | 0 |
| K004017 | H-SCRIBE | Mortara Instrument, Inc. | 2001-06-11 | 166 | 2 |
| K992706 | GALIX GBI -3S-LP | Galix Biomedical Instrumentation, Inc. | 2001-03-15 | 581 | 0 |
| K003940 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-02-08 | 49 | 0 |
| K003763 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-01-05 | 30 | 0 |
| K993788 | R.TEST EVOLUTION | Novacor Div. | 2000-08-04 | 269 | 0 |
| K992197 | MODIFICATION TO ZYMED HOLTER 2000 | Zymed Medical Instrumentation | 1999-07-28 | 28 | 0 |
| K990170 | HOLTER 2000 | Zymed Medical Instrumentation | 1999-04-13 | 84 | 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