# K162159: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Vr Medical Technologies, LLC
- Decided: Apr 28, 2017 after 269 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945062 (1995). 32 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140634: extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit, Devon Medical, Inc. (2014) Summary page 4.
- K112458: Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System, Medica-Rents Co., Ltd. (2012) Summary page 4.
- K132252: Extricare 100CC/ 250CC/ 400CC Canisters, Devon Medical (2013) Summary page 4.

## Most influential descendants
- K211571: Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (2022), 0 descendants of its own
- K202823: Innomed NPWT Silicone Foam Dressing (2021), 0 descendants of its own
- K182458: Longterm NPWT Foam Dressing Kit (2019), 0 descendants of its own

## Indications for use
The VR Medical VCare 1000-300S Negative Pressure Wound Therapy System is an integrated wound management system, indicated for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Source page: https://510kreport.com/device/K162159
Methodology: https://510kreport.com/methodology