# K133333: Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ocean Medical Product, LLC
- Decided: Dec 31, 2014 after 428 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: 6 generations back to K945062 (1995). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092992: A4-XLR8 Foam Dressing, Genadyne Biotechnologies, Inc. (2010) Summary page 4.

## Most influential descendants
- K161570: Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large (2016), 2 descendants of its own
- K211277: Theia NPWT Foam Wound Dressing Kit (2021), 1 descendant of its own
- K232379: PREVENT Kit (2024), 0 descendants of its own
- K150459: FloSure Ventilation Patch (2016), 0 descendants of its own

## Indications for use
The UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam 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 UNI NPWT Foam 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/K133333
Methodology: https://510kreport.com/methodology