# K173407: VT - 100, VT - 200

- Pathway: 510(k) (Traditional)
- Applicant: Carilex Medical, Inc.
- Decided: Aug 9, 2018 after 281 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: 5 generations back to K945062 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112853: Voltera Powered Suction Pump, Suzric Enterprise Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K231646: Carilex VT¿200-i NX (2024), 0 descendants of its own

## Indications for use
Carilex VT - 100/VT - 200 is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VT + 100/VT - 200 suction therapy unit is indicated on use with patients with the following wounds: © Traumatic ® Dehisced wounds e Partial-thickness burns e Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers e Acute wounds e Flaps and grafts

Source page: https://510kreport.com/device/K173407
Methodology: https://510kreport.com/methodology