Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NYU · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112477 | PALINDROME H, SI, HSI CHRONIC CATHETER | Covidien | 2011-09-28 | 30 | 65 |
| K060509 | PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WIT | Tyco Healthcare Group | 2006-06-23 | 116 | 4 |
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