# K131221: Larval Debridement Therapy Products - Biobag 50/100/200/300/400

- Pathway: 510(k) (Traditional)
- Applicant: Biomonde
- Decided: Aug 28, 2013 after 120 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: 2 generations back to K033391 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K123449: Biomonde Larvae, Biomonde (A Trading Name of Zoobiotic Limited) (2013) Summary page 1.

## Most influential descendants
- 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 - 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.

Source page: https://510kreport.com/device/K131221
Methodology: https://510kreport.com/methodology
