# K231646: Carilex VT¿200-i NX

- Pathway: 510(k) (Traditional)
- Applicant: Carilex Medical, Inc.
- Decided: Apr 17, 2024 after 317 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173407: VT - 100, VT - 200, Carilex Medical, Inc. (2018) Summary page 5.
- K142916: SVED Wound Treatment System, Cardinalhealth (2015) Summary page 5.

## Indications for use
The "Carilex" VT · 200-i NX suction therapy unit is indicated on use with 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 The device is not intended for home use. Wound irrigation/Instillation function is not intended for use in a homecare setting.

Source page: https://510kreport.com/device/K231646
Methodology: https://510kreport.com/methodology