Atlas FDA

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

Unomedical Sdn Bhd — Predicate Candidate Screening

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

53 daysmedian FDA review time
394 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973076EUROMEDICAL HAEMATURIA FOLEY CATHETERUnomedical Sdn Bhd1998-09-163940
K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEUnomedical Sdn Bhd1996-11-211540
K954754WIRE REINFORCED SILICONE ENDOTRACHEAL TUBEUnomedical Sdn Bhd1995-12-08530
K954751SILICONE ENDOTRACHEAL TUBEUnomedical Sdn Bhd1995-12-08530
K954750PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBEUnomedical Sdn Bhd1995-12-08530
K954753PEDIATRIC SILICONE ENDOTRACHEAL TUBEUnomedical Sdn Bhd1995-12-08530
K951696ENDOTRACHEAL TUBEUnomedical Sdn Bhd1995-05-22400
K951697PEDIATRIC ENDOTRACHEAL TUBEUnomedical Sdn Bhd1995-05-22400
K945806SILICATH ALL SILICONE FOLEY CATHETERUnomedical Sdn Bhd1995-03-211130

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