Cleared Traditional

K110042 - MANUKATEX

K110042 · Manuka Medical Limited · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
77d
Days
-
Risk

K110042 is an FDA 510(k) clearance for the MANUKATEX. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Manuka Medical Limited (Laguna Niguel, US). The FDA issued a Cleared decision on March 24, 2011 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K110042

510(k) Number K110042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2011
Decision Date March 24, 2011
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 685
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K110042.
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744 · B.Braun Medical, Inc. · Apr 2011
HYLATOPICPLUS CREAM
K110727 · Precision Dermatology Incorporated · Apr 2011
CHLORASHIELD TM ANTIMICROBIAL DRESSING
K103106 · Care Fusion 213, LLC · Mar 2011
SILVER ANTIMICROBIAL WOUND GEL
K110458 · Advanced Medical Solutions Limited · Mar 2011
MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
K101793 · Derma Sciences, Inc. · Feb 2011
HYPO CLENZ WOUND WASH MODEL 100 PPM
K100948 · Nevoa Life Sciences, LLC · Feb 2011
K110042 · MANUKATEX
Download PDF FDA Summary Manuka Medical Limited