Cleared Traditional

K053613 - L-MESITRAN HYDRO

K053613 · Theo Manufacturing BV · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
575d
Days
-
Risk

K053613 is an FDA 510(k) clearance for the L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Theo Manufacturing BV (Bailey, US). The FDA issued a Cleared decision on July 25, 2007 after a review of 575 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 Theo Manufacturing BV devices

FDA 510(k) Submission Details - K053613

510(k) Number K053613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2005
Decision Date July 25, 2007
Days to Decision 575 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
460d slower than avg
Panel avg: 115d · This submission: 575d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 261
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K053613.
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
K072956 · Derma Sciences, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005