Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tyco Healthcare/Kendall · 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) |
|---|---|---|---|---|---|
| K060339 | KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH | Tyco Healthcare/Kendall | 2006-04-28 | 77 | 11 |
| K051805 | KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), K | Tyco Healthcare/Kendall | 2005-10-13 | 100 | 0 |
| K040511 | SCD EXPRESS PORTABLE COMPRESSION SYSTEM | Tyco Healthcare/Kendall | 2004-06-28 | 122 | 0 |
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | Tyco Healthcare/Kendall | 2004-05-05 | 97 | 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