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

Molnlycke Health Care · Predicate Candidate Screening

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

183 daysmedian FDA review time

401 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K130852	AVANCE® FOAM ABDOMINAL DRESSING KIT	Molnlycke Health Care	2014-04-14	382
K130040	MEPITEL AG	Molnlycke Health Care	2014-02-12	401
K123892	MEPILEX TRANSFER AG	Molnlycke Health Care	2013-04-05	108
K122132	AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PA	Molnlycke Health Care	2013-01-17	183
K102923	BARRIER N95 PARTICULATE RESPIRATOR	Molnlycke Health Care	2010-11-19	49
K100029	MEPILEX BORDER AG DRESSING	Molnlycke Health Care	2010-09-15	252
K061554	MEPILEX AG ABSORBENT SILICONE-COATED DRESSING	Molnlycke Health Care	2007-01-25	234
K050786	BARRIER SURGICAL GOWNS	Molnlycke Health Care	2005-05-09	42
K031131	KLINIDRAPE SURGICAL DRAPES	Molnlycke Health Care	2003-06-10	62

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