Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
The Kendall Company Div. of Tyco Healthcare Group · 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) |
|---|---|---|---|---|---|
| K024010 | DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER | The Kendall Company Div. of Tyco Healthcare Group | 2003-06-11 | 189 | 1 |
| K831081 | EZEE FILTER/SEPARATOR | The Kendall Company Div. of Tyco Healthcare Group | 1983-05-16 | 42 | 0 |
| K831082 | CONNECTING TUBING | The Kendall Company Div. of Tyco Healthcare Group | 1983-05-09 | 35 | 0 |
| K831079 | LIQUIPETTE | The Kendall Company Div. of Tyco Healthcare Group | 1983-04-28 | 24 | 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