# K132080: Snap Wound Care System

- Pathway: 510(k) (Traditional)
- Applicant: Spiracur, Inc.
- Decided: Mar 12, 2014 after 250 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). 3 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN080011: Snap Wound Care Device, Spiracur, Inc. (2009). Our reading of the summary gave K081406, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080011, Snap Wound Care Device (Spiracur, Inc.), granted Aug 7, 2009; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K111393: Snap (R) Wound Care System, Spiracur, Inc. (2011) Summary page 3.
- K112341: Snap Wound Care System, Spiracur, Inc. (2011)

## Cited in the summary but kept off the family tree
- K130032: SNaP Wound Care System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K142272: SNaP Wound Care System (2014), 11 descendants of its own
- K151710: SNaP Wound Care System (2015), 10 descendants of its own
- K200305: NPseal (2020), 6 descendants of its own
- K211130: NPseal (2021), 5 descendants of its own
- K212971: NPseal (2022), 4 descendants of its own

## 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 bums, ulcers (such as diabetic, venous or pressure), surgically, closed incisions, flaps and grafts.

Source page: https://510kreport.com/device/K132080
Methodology: https://510kreport.com/methodology