510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K123449Substantially Equivalent

Biomonde Larvae

Biomonde (A Trading Name of Zoobiotic Limited), Southbrough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123449 is the FDA 510(k) clearance record for BIOMONDE LARVAE, cleared for Biomonde (A Trading Name of Zoobiotic Limited) on under FDA product code NQK (Maggots, Medical). FDA's definition for product code NQK reads: "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...". FDA records list one 510(k) clearance for Biomonde (A Trading Name of Zoobiotic Limited). As of , FDA records show no recalls naming K123449.

Clearance record

Decision date
Received
(116 days to decision)
Product code
NQK Maggots, Medical
Device class
Unclassified
Review panel
Unknown
Applicant
Biomonde (A Trading Name of Zoobiotic Limited) 225 Tpke. Rd., Southbrough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQK

Trailing 12 months

FDA records hold no clearances under product code NQK in the trailing twelve months.

FDA records show no clearances under product code NQK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260