Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DPS — Predicate Candidate Screening
576 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
281 days90th percentile
576clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | 2026-07-02 | 330 | 0 |
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 | 241 | 0 |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | 2025-12-22 | 146 | 0 |
| K252474 | Withings BeamO (SCT02) | Withings | 2025-11-10 | 96 | 0 |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | 2025-08-06 | 161 | 0 |
| K243252 | ZBPro Diagnostic | Zbeats, Inc. | 2025-07-10 | 268 | 0 |
| K243305 | Masimo W1 | Masimo Corporation | 2025-04-03 | 164 | 0 |
| K241217 | CloudHRV™ System (100-01-001) | Inmedix, Inc. | 2025-01-16 | 260 | 0 |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 | 200 | 4 |
| K240229 | Masimo W1 | Masimo Corporation | 2024-08-08 | 192 | 0 |
| K232161 | DeepRhythm Platform | Medicalgorithmics S.A. | 2024-06-20 | 336 | 0 |
| K233266 | MEDIBLU ECG SYSTEM | Mediblu Medical, LLC | 2024-06-12 | 257 | 0 |
| K232035 | Impala | AliveCor, Inc. | 2024-06-07 | 336 | 0 |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 | 268 | 0 |
| K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024-05-02 | 262 | 0 |
| K232823 | MCG-S (AM1000) | Amcg Co., Ltd. | 2024-04-05 | 205 | 0 |
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023-12-15 | 238 | 0 |
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | 2023-11-21 | 239 | 0 |
| K232512 | Masimo W1 | Masimo Corporation | 2023-11-17 | 91 | 0 |
| K232974 | EKGenius Smart System | Ekgenius, LLC | 2023-11-17 | 57 | 0 |
| K231150 | Cardio P1 | Bionet Co., Ltd. | 2023-11-09 | 202 | 0 |
| K230812 | Withings Scan Monitor 2.0 | Withings | 2023-08-23 | 152 | 0 |
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023-07-28 | 233 | 0 |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | 2023-07-28 | 308 | 0 |
| K223013 | AccurECG Analysis System | Accurkardia, Inc. | 2023-06-23 | 267 | 0 |
| K221260 | CSF-3 | Cardiacsense | 2023-01-06 | 249 | 0 |
| K221141 | PageWriter TC35 Cardiograph | Medizin Systeme Boblingen GmbH | 2022-12-02 | 227 | 0 |
| K220535 | Cardio10 | Bionet Co., Ltd. | 2022-11-15 | 264 | 0 |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 | 165 | 1 |
| K212163 | Coala Heart Monitor | Coala Life AB | 2022-04-14 | 276 | 0 |
| K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022-04-07 | 261 | 0 |
| K220362 | LE-12CH | Caf Medical Solutions, Inc. | 2022-03-25 | 45 | 0 |
| K212112 | Cardiologs Holter Platform | Cardiologs Technologies | 2021-11-18 | 135 | 0 |
| K201456 | Scan Monitor | Withings SA | 2021-10-05 | 491 | 1 |
| K210140 | electrocardiograph: SE-1202 | Edan Instruments, Inc. | 2021-10-01 | 255 | 0 |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, | Philips Medical Systems | 2021-06-30 | 125 | 0 |
| K203786 | MAC 7 - Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2021-04-30 | 123 | 0 |
| K200884 | B-Secur HeartKey Software Library | B-Secur , Ltd. | 2020-12-07 | 249 | 0 |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, Pa | Philips Medical Systems | 2020-09-29 | 459 | 0 |
| K193415 | physIQ Heart Rhythm and Respiration Module | Physiq, Inc. | 2020-06-11 | 185 | 0 |
| K200036 | AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. | 2020-03-20 | 72 | 0 |
| K183425 | CARDIOVIT AT-102 G2 | Schiller AG | 2020-03-02 | 447 | 1 |
| K191692 | KardioScreen | Imedrix Inc. (Formerly Piitech Inc.) | 2020-01-10 | 199 | 0 |
| K183322 | physIQ Heart Rhythm and Respiratory Module | Physiq, Inc. | 2019-07-10 | 222 | 0 |
| K182571 | CardioFlux with Faraday Analytical Cloud | Genetesis, Inc. | 2019-03-15 | 178 | 0 |
| K182093 | ZOLL ECG Analysis Software | Zoll Manufacturing Corporation | 2019-01-28 | 178 | 0 |
| K183369 | COR12 ECG | Corscience GmbH & Co. | 2018-12-28 | 24 | 0 |
| K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. | 2018-12-14 | 74 | 0 |
| K181998 | CardioBand ECG Event Recorder | Samsung Strategy and Innovation Center (Ssic) | 2018-11-15 | 112 | 0 |
| K173830 | MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2018-09-18 | 274 | 3 |
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