510(k) Report

FDA product code · General and plastic surgery

Maggots, Medical

NQKClass U510(k) required6 decisions since 20041 recall

6 FDA decisions since 2004. 1 recall names this code; it is not Class I. The most-cited predicate is K033391, named by 3 later devices.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of NQK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NQK

1in 2014

2007: 12011: 12013: 22014: 1
2007high 2 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQK

Too few NQK 510(k)s in any year since 2007 to give a median.

Recalls per year · NQK

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NQK

1in 2019

2009: 22019: 1
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code NQK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—12
20100—00
20111—00
20120—00
20132—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NQK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NQK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report