Atlas FDA

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

Laboratoires Urgo — Predicate Candidate Screening

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

152 daysmedian FDA review time
291 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K143017Urgoclean Ag, Antibacterial Absorbent Wound Dressing with SiLaboratoires Urgo2015-08-072910
K123219URGOCLEAN ABSORBENT WOUND DRESSINGLaboratoires Urgo2013-03-181540
K100429URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERLaboratoires Urgo2010-06-111150
K100430URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERLaboratoires Urgo2010-06-111150
K062559URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVERLaboratoires Urgo2007-01-291520
K061220URGOTUL AGLaboratoires Urgo2006-07-27870

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