# DEN080011: Snap Wound Care Device

- Pathway: De Novo (Post-NSE)
- Applicant: Spiracur, Inc.
- Decided: Aug 7, 2009 after 277 days
- Product code: OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus)
- Device class: 2
- Regulation: 21 CFR 878.4683
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K111393: Snap (R) Wound Care System (2011), 15 descendants of its own
- K112341: Snap Wound Care System (2011), 14 descendants of its own
- K132080: Snap Wound Care System (2014), 12 descendants of its own
- K142272: SNaP Wound Care System (2014), 11 descendants of its own
- K151710: SNaP Wound Care System (2015), 10 descendants of its own

Source page: https://510kreport.com/device/DEN080011
Methodology: https://510kreport.com/methodology