Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Covidien, LLC, Formerly Registered AS Tyco Healthca · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-12-22 | 103 | 25 |
| K102325 | IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE US | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-10-13 | 57 | 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