Cleared Traditional

K123449 - BIOMONDE LARVAE

K123449 · Biomonde (A Trading Name of Zoobiotic Limited) · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
116d
Days
-
Risk

K123449 is an FDA 510(k) clearance for the BIOMONDE LARVAE. Classified as Maggots, Medical (product code NQK).

Submitted by Biomonde (A Trading Name of Zoobiotic Limited) (Southbrough, US). The FDA issued a Cleared decision on March 5, 2013 after a review of 116 days - within the typical 510(k) review window.

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 - K123449

510(k) Number K123449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2012
Decision Date March 05, 2013
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

NQK Device Classification - Class 0,

Product Code NQK Maggots, Medical
Device Class -
Definition Phaenicia Sericacta (blow Fly) Larvae Are Harvested And Provided Disinfected For Use In Debriding Non-healing Necrotic Skin And Soft Tissue Wounds, Including Pressure Ulcers, Venous Stasis Ulcers, Neuropathic Foot Ulcers, And Non-healing Traumatic Or Post Surgical Wounds. See Federal Register Notice At 89 Fr 106521 “transfer Of Regulatory Responsibility From The Center For Devices And Radiological Health To The Center For Biologics Evaluation And Research; Medical Maggots And Medicinal Leeches” (frn) (fda-2024-n-5702)

Regulatory Peers - NQK Maggots, Medical

Devices cleared under the same product code (NQK) and FDA review panel - the closest regulatory comparables to K123449.
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K123449 · BIOMONDE LARVAE
Download PDF FDA Summary Biomonde (A Trading N…