Cleared Traditional

K130040 - MEPITEL AG

K130040 · Molnlycke Health Care · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
401d
Days
-
Risk

K130040 is an FDA 510(k) clearance for the MEPITEL AG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on February 12, 2014 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Molnlycke Health Care devices

FDA 510(k) Submission Details - K130040

510(k) Number K130040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2013
Decision Date February 12, 2014
Days to Decision 401 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
286d slower than avg
Panel avg: 115d · This submission: 401d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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