# K113032: Snap Wound Care System

- Pathway: 510(k) (Traditional)
- Applicant: Spiracur, Inc.
- Decided: Dec 1, 2011 after 50 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
Longest line of descent: 3 generations back to DEN080011 (2009). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111393: Snap (R) Wound Care System, Spiracur, Inc. (2011) Summary page 2.
- K112341: Snap Wound Care System, Spiracur, Inc. (2011)
- K091585: Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100, Kci USA, Inc. (2009) Summary page 2.

## Indications for use
The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), Surgically closed incisions, flaps and grafts.

Source page: https://510kreport.com/device/K113032
Methodology: https://510kreport.com/methodology