510(k) · Cleared

Cleared

Biomonde Larvae

K123449510(k) TraditionalCleared Mar 5, 2013116-day reviewClass U

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

Biomonde (A Trading Name of Zoobiotic Limited) · NQK Maggots, Medical

Cleared on Mar 5, 2013 as substantially equivalent to K033391 (Ronald A. Sherman, 2004) after a 116-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.

Decided: Mar 5, 2013
Review: 116 days
Class: Class U
Product code: NQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K033391 (2004). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK033391 Medical MaggotsRonald A. Sherman · 2004
This deviceK123449 Biomonde LarvaeBiomonde (A Trading Name of Zoobiotic Limited) · 2013
Descendant · cites it directly · 1 of its ownK131221 Larval Debridement Therapy Products - Biobag 50/100/200/300/400Biomonde · 2013
Descendant · cites it directly · 0 of its ownK142020 Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag…Biomonde · 2014

Most influential descendants

Showing 2 of 2 · See all

K131221Larval Debridement Therapy Products - Biobag 50/100/200/300/400Biomonde · 2013 · cites it directly1descendant
K142020Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag 50/100/200/300/400Biomonde · 2014 · 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)	K123449	Biomonde Larvae	Biomonde (A Trading Name of Zoobiotic Limited)	2013	—
+1	K131221	Larval Debridement Therapy Products - Biobag 50/100/200/300/400	Biomonde	2013	—
+1	K142020	Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag…	Biomonde	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0

FIG. 1 — Lineage of K123449, 2004–2014Source: 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 …apy Products -Larvae 100/200/300 Common/Usual Name: Maggots Classification Name:. Unclassified 3. PREDICATE DEVICE Medical Maggots (K033391; Procode: NQK) 4. DEVICE DESCRIPTION The BioMonde Larvae 100/200/300 products are live larvae, stage Land 11, of the gre…	Ronald A. Sherman	2004	—

Also cleared against K033391: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131221	Larval Debridement Therapy Products - Biobag 50/100/200/300/400	Biomonde	2013	1
K142020	Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag 50/100/200/300/400	Biomonde	2014	0

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?

Its one ancestor has no recall.
Of its descendants, K131221 (Biomonde, 2013) has gone furthest, with 1 descendant 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. 2013, 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?

The BioMonde Larval Debridement Therapy Products - Larvae 100/200/300 are

indicated for debridement of 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123449 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123449: Biomonde Larvae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123449

Report an extraction error

Are you the manufacturer?

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