# K211277: Theia NPWT Foam Wound Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Clear Choice Therapeutics, Inc.
- Decided: Dec 16, 2021 after 233 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). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161570: Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large, Lc Medical Concepts, Inc. (2016) Summary page 4.

## Most influential descendants
- K232379: PREVENT Kit (2024), 0 descendants of its own

## Indications for use
The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. The Theia NPWT Foam Wound Dressing 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 Flap and Grafts

Source page: https://510kreport.com/device/K211277
Methodology: https://510kreport.com/methodology