# K123449: Biomonde Larvae

- Pathway: 510(k) (Traditional)
- Applicant: Biomonde (A Trading Name of Zoobiotic Limited)
- Decided: Mar 5, 2013 after 116 days
- Product code: NQK (Maggots, Medical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033391 (2004). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033391: Medical Maggots, Ronald A. Sherman (2004) Summary page 1.

## Most influential descendants
- K131221: Larval Debridement Therapy Products - Biobag 50/100/200/300/400 (2013), 1 descendant of its own
- K142020: Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag 50/100/200/300/400 (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K123449
Methodology: https://510kreport.com/methodology