Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
QDB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. | 2023-07-21 | 87 | 0 |
| K213971 | Atrial Fibrillation History Feature | Apple, Inc. | 2022-06-03 | 165 | 0 |
| K212372 | Fitbit Irregular Rhythm Notifications | Fitbit, Inc. | 2022-04-08 | 252 | 0 |
| K212516 | IRNF App | Apple, Inc. | 2021-10-22 | 73 | 0 |
| DEN180042 | Irregular Rhythm Notification Feature | Apple, Inc. | 2018-09-11 | 33 | 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