510(k) · Cleared

Recalled · 2009

Medical Maggots, Creature Comforts

K072438510(k) TraditionalCleared Oct 5, 200736-day reviewClass URecalls 1

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

Monarch Labs, LLC · NQK Maggots, Medical

Cleared on Oct 5, 2007 as substantially equivalent to K033391 (Ronald A. Sherman, 2004) after a 36-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it. It has been recalled once.

Decided: Oct 5, 2007
Review: 36 days
Class: Class U
Product code: NQK
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K033391 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK033391 Medical MaggotsRonald A. Sherman · 2004
This deviceK072438 Medical Maggots, Creature ComfortsMonarch Labs, LLC · 2007
Descendant · cites it directly · 0 of its ownK102827 Medical Maggots, LesocMonarch Labs, LLC · 2011

Most influential descendants

Showing 1 of 1 · See all

K102827Medical Maggots, LesocMonarch Labs, LLC · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033391	Medical Maggots	Ronald A. Sherman	2004	—
0 (this device)	K072438	Medical Maggots, Creature Comforts	Monarch Labs, LLC	2007	—
+1	K102827	Medical Maggots, Lesoc	Monarch Labs, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K072438, 2004–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K033391	Medical Maggots Summary page 1 …with Creature Comforts or Creature Comforts 11 d) Name and 510(k) number of legally marketed device: Medical Maggots; K033391 The dressings used to confine them on the wound are called "Creature…	Ronald A. Sherman	2004	—

Also cleared against K033391: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102827	Medical Maggots, Lesoc	Monarch Labs, LLC	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 3, 2009	Not classified	Z-2207-2010	Other	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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K102827 (Monarch Labs, LLC, 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K033391.

How does its category compare?

All NQK devices

NQK Maggots, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NQK

1in 2014

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	0	0
2009	0	—	1	2
2010	0	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	2	—	0	0
2014	1	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	1
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Medical Maggots are indicated for 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.

The accessory maggot confinement dressings, Creature Comforts and Creature Comforts II, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072438 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072438: Medical Maggots, Creature Comforts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072438

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026