# K232379: PREVENT Kit

- Pathway: 510(k) (Traditional)
- Applicant: Clear Choice Therapeutics
- Decided: Feb 5, 2024 after 181 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211277: Theia NPWT Foam Wound Dressing Kit, Clear Choice Therapeutics, Inc. (2021) Summary page 6.

## Indications for use
The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris. The PREVENT™ Kit is appropriate for use on the following wounds: • Pressure Ulcers • Diabetic/Neuropathic Ulcers • Venous Insufficiency Ulcers • Traumatic Wounds • Post-Operative and Dehisced Surgical Wounds • Skin Flaps and Grafts The system is for prescription use only.

Source page: https://510kreport.com/device/K232379
Methodology: https://510kreport.com/methodology