Monarch Labs, LLC

Irvine, CA, US

MONARCH LABS, LLC. appears in FDA device records in Irvine, CA. FDA records list 2 510(k) clearances between 2007-10-05 and 2011-11-02, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Monarch Labs, LLC between 2007 and 2011. The busiest year on record is 2007, with 1. The most recent is 2011, with 1.

Clearances by year, as a table

510(k) clearance decisions for Monarch Labs, LLC, by decision year
Year	Clearances
2007	1
2011	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K102827	MEDICAL MAGGOTS, LESOC	NQK	Substantially Equivalent	2011-11-02
K072438	MEDICAL MAGGOTS, CREATURE COMFORTS	NQK	Substantially Equivalent	2007-10-05

Registered establishments

FDA registered establishments for Monarch Labs, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3005735989	3005735989	MONARCH LABS, LLC.	17875 SKY PARK CIRCLE, SUITE K, IRVINE, CA 92614 US	2026	NQK

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

NQKMaggots, Medical

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2207-2010	Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.	Monarch Labs initiated the field notification regarding their Medical Maggots from Batch MM090406 with the accessory LeFlap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch.		2009-05-03	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain