Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Covidien, Formerly Valleylab, A Division of Tyco H · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
278 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | Covidien, Formerly Valleylab, A Division of Tyco H | 2014-08-07 | 72 | 0 |
| K133338 | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING ( | Covidien, Formerly Valleylab, A Division of Tyco H | 2013-12-20 | 51 | 0 |
| K131170 | SONICISION STERILIZATION TRAY | Covidien, Formerly Valleylab, A Division of Tyco H | 2013-08-28 | 126 | 0 |
| K123444 | LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER | Covidien, Formerly Valleylab, A Division of Tyco H | 2013-01-30 | 83 | 0 |
| K113572 | LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER | Covidien, Formerly Valleylab, A Division of Tyco H | 2012-09-05 | 278 | 0 |
| K102913 | FORCETRIAD | Covidien, Formerly Valleylab, A Division of Tyco H | 2011-05-06 | 217 | 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