Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Williams Medical Co. · Predicate Candidate Screening

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

36 daysmedian FDA review time
36 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K891159SODIUM BICARBONATE, U.S.P.Williams Medical Co.1989-04-07320
K854031SNAP-LOCK ADDITIVE CAP #SL100Williams Medical Co.1985-11-06360
K854033SNAP-LOCK ADDITIVE CAP #SL400Williams Medical Co.1985-11-06360
K854034SNAP-LOCK ADDITIVE CAP #SL 300Williams Medical Co.1985-11-06360
K854032SNAP-LOCK ADDITIVE CAP #SL 200Williams Medical Co.1985-11-01310

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