# K172725: VT Dressing Kits

- Pathway: 510(k) (Traditional)
- Applicant: Carilex Medical, Inc.
- Decided: Jun 8, 2018 after 270 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: 4 generations back to K945062 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112458: Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System, Medica-Rents Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K190119: Foryou NPWT Dressing Kit (2019), 0 descendants of its own

## Indications for use
Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris. The Carilex VT Dressing Kits is indicated for use for patients with the following wounds: - Traumatic - Dehisced wounds - Partial-thickness burns - Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers - Acute wounds - Flaps and grafts

Source page: https://510kreport.com/device/K172725
Methodology: https://510kreport.com/methodology