Cleared Traditional

K120976 - MANUKA IG

K120976 · Links Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
51d
Days
-
Risk

K120976 is an FDA 510(k) clearance for the MANUKA IG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Links Medical Products, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on May 23, 2012 after a review of 51 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 - K120976

510(k) Number K120976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date May 23, 2012
Days to Decision 51 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K120976.
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IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
K112549 · Covalontechnologies, Inc. · May 2012
SALINE WOUND WASH
K112666 · Nanoplas, Inc. · Apr 2012
K120976 · MANUKA IG
Download PDF FDA Summary Links Medical Product…