# K201400: npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™

- Pathway: 510(k) (Traditional)
- Applicant: Aatru Medical, LLC
- Decided: Aug 23, 2021 after 452 days
- Product code: QPX (Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical)
- 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 4.

## Indications for use
The Negative Pressure Surgical Incision Management System (npSIMS)™ is indicated for patients who may benefit from wound management via application of negative pressure, as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The npSIMS is indicated for removal of small amounts of exudate from closed surgical incisions.

Source page: https://510kreport.com/device/K201400
Methodology: https://510kreport.com/methodology