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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Molnlycke Health Care, Inc. · Predicate Candidate Screening

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

84 daysmedian FDA review time
112 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K062138POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDERMolnlycke Health Care, Inc.2006-10-05710
K051625BARRIER SURGICAL DRAPESMolnlycke Health Care, Inc.2005-07-14240
K000902KLINIDRAPE REINFORCED SURGICAL GOWNSMolnlycke Health Care, Inc.2000-07-111120
K000901KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONSMolnlycke Health Care, Inc.2000-07-051060
K000906KLINIDRAPE SURGICAL DRAPESMolnlycke Health Care, Inc.2000-06-23940
K984371MEPITEL NON ADHERENT SILICONE DRESSINGMolnlycke Health Care, Inc.1999-03-03860
K984370HYPERGEL 20% HYPERTONIC SALINE GELMolnlycke Health Care, Inc.1999-03-01840
K984368NORMLGEL 0.9% ISOTONIC SALINE GELMolnlycke Health Care, Inc.1999-02-22770
K983554ALLDRESS, ABSORBENT FILM DRESSINGMolnlycke Health Care, Inc.1998-11-10280
K983184MEPILEXMolnlycke Health Care, Inc.1998-10-28470

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