# K193185: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

- Pathway: 510(k) (Traditional)
- Applicant: Benq Materials Corporation
- Decided: May 4, 2020 after 168 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
SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials. SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types: * Chronic wounds * Acute wounds * Traumatic wounds * Subacute and dehisced wounds * Partial-thickness burns * Ulcers (such as diabetic or pressure) * Flaps and grafts * Closed surgical incisions

Source page: https://510kreport.com/device/K193185
Methodology: https://510kreport.com/methodology