# K202823: Innomed NPWT Silicone Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Longterm Medical Technology Co., Ltd.
- Decided: Dec 15, 2021 after 447 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). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 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.
- K151436: PICO Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical, Ltd. (2016) Summary page 4.

## Indications for use
Innomed NPWT Silicone Foam Dressing 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. When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types: • Chronic • Acute • Traumatic • Subacute and dehisced wounds • Partial-thickness burns, • Ulcers (such as diabetic or pressure) • Flaps and grafts The device is for use in professional healthcare facilities only.

Source page: https://510kreport.com/device/K202823
Methodology: https://510kreport.com/methodology