Cleared Traditional

MEDICAL MAGGOTS, CREATURE COMFORTS (K072438) - FDA 510(k) Clearance

K072438 · Monarch Labs, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2007
Decision
36d
Days
-
Risk

K072438 is an FDA 510(k) clearance for the MEDICAL MAGGOTS, CREATURE COMFORTS. Classified as Maggots, Medical (product code NQK).

Submitted by Monarch Labs, LLC (Irvine, US). The FDA issued a Cleared decision on October 5, 2007 after a review of 36 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.

View all Monarch Labs, LLC devices

Submission Details

510(k) Number K072438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2007
Decision Date October 05, 2007
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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)