510(k) · Cleared

Cleared

Medical Maggots, Lesoc

K102827510(k) SpecialCleared Nov 2, 2011399-day reviewClass U

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 Nov 2, 2011 as substantially equivalent to K033391 (Ronald A. Sherman, 2004) and 1 other predicate after a 399-day review. Its family tree reaches back 2 generations to 2004.

Decided: Nov 2, 2011
Review: 399 days
Class: Class U
Product code: NQK
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K033391 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK033391 Medical MaggotsRonald A. Sherman · 2004
1 generation backK072438 Medical Maggots, Creature ComfortsMonarch Labs, LLC · 2007 · Recalled
This deviceK102827 Medical Maggots, LesocMonarch Labs, LLC · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K033391	Medical Maggots	Ronald A. Sherman	2004	—
−1	K072438	Medical Maggots, Creature Comforts	Monarch Labs, LLC	2007	1
0 (this device)	K102827	Medical Maggots, Lesoc	Monarch Labs, LLC	2011	—

FIG. 1 — Lineage of K102827, 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

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What was it cleared against? (2)

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 …d associated dressings (including Creature Comforts & Creature Comforts Nylon Stockings); K033391. Medical Maggots and associated dressings (including LeFlap…	Ronald A. Sherman	2004	—
*	K072438	Medical Maggots, Creature Comforts Summary page 1 …K033391. Medical Maggots and associated dressings (including LeFlap dual-layered dressing); K072438. e) Classification: This is a pre-amendmcnt device, still unclassified. Product Code:…	Monarch Labs, LLC	2007	1

Also cleared against K033391: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
1 of the 2 ancestors has a recall of any class.
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. 2011, 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 ComfortsTM , and LeFlapTM and LeSocTM, 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/K102827 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102827: Medical Maggots, Lesoc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102827

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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