Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QDA — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
450 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240795 | Withings ECG App | Withings | 2025-06-15 | 450 | 0 |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop., Inc. | 2025-04-04 | 176 | 0 |
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024-08-02 | 122 | 0 |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm | Samsung Electronics Co., Ltd. | 2023-05-02 | 89 | 0 |
| K221774 | Garmin ECG App | Garmin International, Inc. | 2023-01-12 | 205 | 0 |
| K201525 | ECG App | Apple, Inc. | 2020-10-08 | 122 | 0 |
| K200948 | Fitbit ECG App | Fitbit, Inc. | 2020-09-11 | 156 | 0 |
| K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | 2020-08-04 | 95 | 0 |
| DEN180044 | ECG App | Apple, Inc. | 2018-09-11 | 28 | 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