Atlas FDA

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

Welmed Systems, Inc. — Predicate Candidate Screening

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

27 daysmedian FDA review time
67 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K863281CARE + PLUS IRREGATION TRAYWelmed Systems, Inc.1986-10-31670
K863282CARE + PLUS CATHETER CARE TRAYWelmed Systems, Inc.1986-10-31670
K863497SUCTION CATHETER KITWelmed Systems, Inc.1986-10-06270
K863284I.V. START KITWelmed Systems, Inc.1986-09-22280
K863283CARE + PLUS SUTURE REMOVAL TRAYWelmed Systems, Inc.1986-09-15210
K862663TRACHEOSTOMY CARE TRAYWelmed Systems, Inc.1986-07-30160
K862219T.P.N. DRESSING CHANGE TRAYWelmed Systems, Inc.1986-07-08270

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