Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Covidien Lp, Formerly Registered AS Tyco Healthcar · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100548 | VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SH | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2010-04-26 | 59 | 0 |
| K093372 | SILS PORT MODEL SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009-12-03 | 35 | 0 |
| K082296 | COPA AMD | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009-02-26 | 198 | 0 |
| K073122 | MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC N | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2007-11-21 | 15 | 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