Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
AliveCor, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
336 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252589 | Corvair Monza | AliveCor, Inc. | 2026-01-09 | 147 | 0 |
| K231010 | Corvair | AliveCor, Inc. | 2024-06-07 | 427 | 0 |
| K232035 | Impala | AliveCor, Inc. | 2024-06-07 | 336 | 0 |
| K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022-05-25 | 107 | 0 |
| K212662 | AliveCor QT Service | AliveCor, Inc. | 2022-04-26 | 246 | 0 |
| K211668 | KardiaMobile Card | AliveCor, Inc. | 2021-11-30 | 182 | 0 |
| K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021-06-30 | 107 | 0 |
| K201985 | KardiaAI | AliveCor, Inc. | 2020-11-12 | 118 | 0 |
| K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2020-01-24 | 241 | 0 |
| K183319 | Triangle System | AliveCor, Inc. | 2019-05-10 | 161 | 0 |
| K182396 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2019-04-12 | 220 | 0 |
| K181823 | KardiaAI | AliveCor, Inc. | 2019-03-11 | 245 | 0 |
| K171816 | Kardia Band System | AliveCor, Inc. | 2017-11-16 | 150 | 0 |
| K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015-01-27 | 125 | 0 |
| K142672 | AliveCor Heart Monitor | AliveCor, Inc. | 2014-12-03 | 75 | 0 |
| K140933 | ALIVECOR HEART MONITOR | AliveCor, Inc. | 2014-08-15 | 126 | 1 |
| K130921 | ALIVECOR HEART MONITOR OTC | AliveCor, Inc. | 2014-02-06 | 309 | 0 |
| K130409 | ALIVECOR HEART MONITOR | AliveCor, Inc. | 2013-09-06 | 199 | 0 |
| K122356 | ALIVECOR HEART MONITOR FOR IPHONE | AliveCor, Inc. | 2012-11-19 | 108 | 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