Cleared Traditional

K133729 - WOUND DRESSING WITH MANUKA HONEY

K133729 · Manuka Health New Zealand , Ltd. · General & Plastic Surgery device
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Jan 2015
Decision
413d
Days
-
Risk

K133729 is an FDA 510(k) clearance for the WOUND DRESSING WITH MANUKA HONEY. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Manuka Health New Zealand , Ltd. (Bridgewater, US). The FDA issued a Cleared decision on January 23, 2015 after a review of 413 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 Manuka Health New Zealand , Ltd. devices

FDA 510(k) Submission Details - K133729

510(k) Number K133729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2013
Decision Date January 23, 2015
Days to Decision 413 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
298d slower than avg
Panel avg: 115d · This submission: 413d
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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