Atlas FDA

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

Westmed Intl. — Predicate Candidate Screening

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

93 daysmedian FDA review time
275 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955047WESTMED CIRCULARIE PEP DEVICESWestmed Intl.1996-03-271450
K954271WESTMED CONDESATE COLLECTION TRAPWestmed Intl.1995-12-281070
K952616MICROTIMEWestmed Intl.1995-09-271130
K953687WESTMED PEDIATRIC BACTERIAL/VIRAL FILTERWestmed Intl.1995-09-18420
K953506WESTMED RESPIRATORY LUER ADAPTORWestmed Intl.1995-09-15510
K951484WESTMED BACTERIAL/VIRAL FILTERWestmed Intl.1995-04-24250
K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.1995-02-07910
K924944INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRAWestmed Intl.1993-07-022750
K925173BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINTWestmed Intl.1993-01-15930

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