Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott (St. Jude Medical) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
109 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2021-08-13 | 29 | 0 |
| K202876 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020-12-01 | 64 | 0 |
| K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020-11-23 | 56 | 0 |
| K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | 2020-06-03 | 76 | 0 |
| K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Appli | Abbott (St. Jude Medical) | 2020-03-17 | 109 | 0 |
| K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2019-04-10 | 58 | 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