Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Covidien Lp, Formerly Registered AS Kendall · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR | Covidien Lp, Formerly Registered AS Kendall | 2013-04-17 | 30 | 3 |
| K112511 | DOBBHOFF DUAL PORT FEEDING TUBE | Covidien Lp, Formerly Registered AS Kendall | 2012-05-11 | 255 | 0 |
| K092205 | PALINDROME P HEMODIALYSIS CATHETER | Covidien Lp, Formerly Registered AS Kendall | 2009-10-30 | 100 | 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