510(k) · Cleared
ClearedLarval Debridement Therapy Products - Biobag 50/100/200/300/400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomonde · NQK Maggots, Medical
Cleared on Aug 28, 2013 as substantially equivalent to K123449 (Biomonde (A Trading Name of Zoobiotic Limited), 2013) after a 120-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Aug 28, 2013
- Review
- 120 days
- Class
- Class U
- Product code
- NQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033391 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033391 Medical MaggotsRonald A. Sherman · 2004
- 1 generation backK123449 Biomonde LarvaeBiomonde (A Trading Name of Zoobiotic Limited) · 2013
- This deviceK131221 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K033391 | Medical Maggots | Ronald A. Sherman | 2004 | — |
| −1 | K123449 | Biomonde Larvae | Biomonde (A Trading Name of Zoobiotic Limited) | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2014 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K123449 | Biomonde LarvaeSummary page 1…00 Common/Usual Name: Maggots Classification Name: Unclassified 3. PREDICATE DEVICE BioMonde Larval Debridement Therapy Products - Larvae 100/200/300 (K 123449) 4. l)EvicE DESCRIPTION The BioMondle BioBag 50/l00/200/300/400 products are live larvae, stage I and 11,of the gre… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142020 | Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag 50/100/200/300/400 | 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142020 (Biomonde, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123449.
How does its category compare?
All NQK devicesNQK 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
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?
The BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 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/K131221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131221: Larval Debridement Therapy Products - Biobag 50/100/200/300/400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131221
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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