510(k) · Cleared
ClearedMedical Maggots
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ronald A. Sherman · NQK Maggots, Medical
Cleared on Jan 12, 2004 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jan 12, 2004
- Review
- 81 days
- Class
- Class U
- Product code
- NQK
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK033391 Medical MaggotsRonald A. Sherman · 2004
- Descendant · cites it directly · 2 of its ownK123449 Biomonde LarvaeBiomonde (A Trading Name of Zoobiotic Limited) · 2013
- Descendant · 2 generations on · 1 of its ownK131221 Larval Debridement Therapy Products - Biobag 50/100/200/300/400Biomonde · 2013
- Descendant · cites it directly · 1 of its ownK072438 Medical Maggots, Creature ComfortsMonarch Labs, LLC · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK142020 Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag…Biomonde · 2014
- Descendant · cites it directly · 0 of its ownK102827 Medical Maggots, LesocMonarch Labs, LLC · 2011
Most influential descendants
Showing 5 of 5 · See all- K123449Biomonde LarvaeBiomonde (A Trading Name of Zoobiotic Limited) · 2013 · cites it directly2descendants
- K131221Larval Debridement Therapy Products - Biobag 50/100/200/300/400Biomonde · 2013 · 2 generations on1descendant
- K072438Medical Maggots, Creature ComfortsMonarch Labs, LLC · 2007 · cites it directly1descendant
- K142020Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag 50/100/200/300/400Biomonde · 2014 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K033391 | Medical Maggots | Ronald A. Sherman | 2004 | — |
| +1 | K123449 | Biomonde Larvae | Biomonde (A Trading Name of Zoobiotic Limited) | 2013 | — |
| +2 | K131221 | Larval Debridement Therapy Products - Biobag 50/100/200/300/400 | Biomonde | 2013 | — |
| +1 | K072438 | Medical Maggots, Creature Comforts | Monarch Labs, LLC | 2007 | 1 |
| +2 | K142020 | Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag… | Biomonde | 2014 | — |
| +1 | K102827 | Medical Maggots, Lesoc | Monarch Labs, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K123449 (Biomonde (A Trading Name of Zoobiotic Limited), 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NQK devicesNQK Maggots, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQK
1in 2014
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQK
1in 2019
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?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033391 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033391: Medical Maggots.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033391
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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