# K212971: NPseal

- Pathway: 510(k) (Traditional)
- Applicant: Guard Medical, Inc.
- Decided: Feb 10, 2022 after 146 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: 8 generations back to DEN080011 (2009). 8 ancestors in all.
4 later devices descend 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)
- K211130: NPseal, Guard Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K240244: NPseal (Small, Medium, Large) (2024), 3 descendants of its own
- K241522: NPseal (20 and 25) (2024), 2 descendants of its own
- K250708: NPseal (2025), 1 descendant of its own
- 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 a 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/K212971
Methodology: https://510kreport.com/methodology