Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tyco Healthcare Group LP · 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) |
|---|---|---|---|---|---|
| K080898 | AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADI | Tyco Healthcare Group LP | 2008-05-05 | 35 | 24 |
| K071371 | COPA AMD ANTIMICROBIAL WOUND DRESSING | Tyco Healthcare Group LP | 2007-11-19 | 187 | 0 |
| K060649 | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303 | Tyco Healthcare Group LP | 2006-05-22 | 70 | 0 |
| K010909 | NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE | Tyco Healthcare Group LP | 2001-04-09 | 14 | 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