# K254160: VacHeal Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: VacHeal, LLC
- Decided: Sep 18, 2026 after 270 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: 6 generations back to DEN080011 (2009). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151710: SNaP Wound Care System, Spiracur, Inc. (2015) Summary page 5.

## Indications for use
The VacHeal™ NPWT System is indicated for patients who would benefit from wound management via application of negative pressure to remove small amounts of exudate from closed surgical incisions.

Source page: https://510kreport.com/device/K254160
Methodology: https://510kreport.com/methodology