FDA product code NQK: Maggots, Medical
NQK is the FDA product code for maggots, medical. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under NQK, from 4 different applicants. The average 510(k) review took 142 days (median 110). FDA has posted 1 recall for NQK devices.
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)
Classification
| Field | Value |
|---|---|
| Device name | Maggots, Medical |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NQK clearance
Top NQK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomonde | 2 | 2014-11-05 |
| Monarch Labs, LLC | 2 | 2011-11-02 |
| Biomonde (A Trading Name of Zoobiotic Limited) | 1 | 2013-03-05 |
| Ronald A. Sherman | 1 | 2004-01-12 |
Most recent NQK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142020 | Biomonde | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 | 2014-11-05 | 103 |
| K131221 | Biomonde | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 | 2013-08-28 | 120 |
| K123449 | Biomonde (A Trading Name of Zoobiotic Limited) | BIOMONDE LARVAE | 2013-03-05 | 116 |
| K102827 | Monarch Labs, LLC | MEDICAL MAGGOTS, LESOC | 2011-11-02 | 399 |
| K072438 | Monarch Labs, LLC | MEDICAL MAGGOTS, CREATURE COMFORTS | 2007-10-05 | 36 |
Recalls for NQK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-05-03.
Frequently asked questions
What is FDA product code NQK?
NQK is the FDA product code for maggots, medical. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is NQK?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQK?
Across 6 cleared submissions the average was 142 days from receipt to decision (median 110).
Which companies have the most NQK clearances?
Biomonde (2); Monarch Labs, LLC (2); Biomonde (A Trading Name of Zoobiotic Limited) (1); Ronald A. Sherman (1).
Have NQK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NQK
- Run a recall and safety report across every NQK manufacturer
- Watch product code NQK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times