Atlas FDA

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

Winfield Co., Inc. — Predicate Candidate Screening

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

144 daysmedian FDA review time
231 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942902SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVERWinfield Co., Inc.1994-12-152310
K942903SHARPS-TAINER SMALL OPENINGWinfield Co., Inc.1994-09-191440
K942901SHARPS-TAINER LARGE OPENINGWinfield Co., Inc.1994-09-191440
K891855WINFIELD LATEX EXAMINATION GLOVESWinfield Co., Inc.1989-06-22870
K802803CONVALESCENT RECLINERWinfield Co., Inc.1980-11-19160

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