# K211571: Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Longterm Medical Technology Co., Ltd.
- Decided: May 31, 2022 after 375 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: 10 generations back to K945062 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162159: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing, Vr Medical Technologies, LLC (2017) Summary page 4.
- K032310: Mini V.a.C., V.a.C. Freedom, V.a.C. Ats, Kinetic Concepts, Inc. (2003) Summary page 4.

## Indications for use
Longterm NPWT Foam Dressing Kit is intended to be used along with VCare 1000 -300S pump 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. Longterm NPWT foam dressing kit is for use in professional healthcare facilities only.

Source page: https://510kreport.com/device/K211571
Methodology: https://510kreport.com/methodology