# K202898: Tzoar 207 Negative Pressure Wound Therapy (NPWT) System

- Pathway: 510(k) (Traditional)
- Applicant: Lightstone Medical Products (Ningbo) Co, Ltd.
- Decided: Dec 30, 2021 after 457 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: 8 generations back to K945062 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132225: Extricare, Devon Medical, Inc. (2014) Summary page 4.

## Indications for use
The Tzoar Negative Pressure Wound Therapy (NPWT) System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is indicated for the following wound types: 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/K202898
Methodology: https://510kreport.com/methodology