# K250708: NPseal

- Pathway: 510(k) (Special)
- Applicant: Guard Medical, Inc.
- Decided: Apr 8, 2025 after 29 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: 11 generations back to DEN080011 (2009). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241522: NPseal (20 and 25), Guard Medical, Inc. (2024) Summary page 5.

## Most influential descendants
- K251156: NPseal (2025), 0 descendants of its own

## Indications for use
The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

Source page: https://510kreport.com/device/K250708
Methodology: https://510kreport.com/methodology