Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

W.G. Whitney Corp. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

29 daysmedian FDA review time
49 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K834532STERILE WET DRESSING PACKW.G. Whitney Corp.1984-01-25350
K813535XEROFORM DRESSINGW.G. Whitney Corp.1982-02-04490
K810406STERILE WET DRESSING PACKW.G. Whitney Corp.1981-03-11210
K803299COLD/HOT PACKW.G. Whitney Corp.1981-01-15160
K800907TOMAC WET DRESSING WARMERW.G. Whitney Corp.1980-05-20290
K781322STERILE WET DRESSING PACKW.G. Whitney Corp.1978-08-17170
K770387UNICATCHW.G. Whitney Corp.1977-04-05360

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