Cleared Traditional

K131221 - LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400

K131221 · Biomonde · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
120d
Days
-
Risk

K131221 is an FDA 510(k) clearance for the LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400. Classified as Maggots, Medical (product code NQK).

Submitted by Biomonde (Marlborough, US). The FDA issued a Cleared decision on August 28, 2013 after a review of 120 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 - K131221

510(k) Number K131221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2013
Decision Date August 28, 2013
Days to Decision 120 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
5d slower than avg
Panel avg: 115d · This submission: 120d
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 K131221.
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400
K142020 · Biomonde · Nov 2014
BIOMONDE LARVAE
K123449 · Biomonde (A Trading Name of Zoobiotic Limited) · Mar 2013
MEDICAL MAGGOTS, LESOC
K102827 · Monarch Labs, LLC · Nov 2011
MEDICAL MAGGOTS, CREATURE COMFORTS
K072438 · Monarch Labs, LLC · Oct 2007
MEDICAL MAGGOTS
K033391 · Ronald A. Sherman · Jan 2004
K131221 · LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
Download PDF FDA Summary Biomonde