Cleared Traditional

K092689 - MANUKAPLI WOUND DRESSING

K092689 · 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
May 2010
Decision
260d
Days
-
Risk

K092689 is an FDA 510(k) clearance for the MANUKAPLI WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Manuka Medical Limited (Laguna Niguel, US). The FDA issued a Cleared decision on May 20, 2010 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092689

510(k) Number K092689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2009
Decision Date May 20, 2010
Days to Decision 260 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
145d slower than avg
Panel avg: 115d · This submission: 260d
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 K092689.
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BARIREP
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VASHE WOUND THERAPY SOLUTION
K093697 · Puricore, Inc. · Apr 2010
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
K092348 · Polyremedy, Inc. · Apr 2010
K092689 · MANUKAPLI WOUND DRESSING
Download PDF FDA Summary Manuka Medical Limited