# K161410: VT·One, VT·One 60days

- Pathway: 510(k) (Traditional)
- Applicant: Carilex Medical, Inc.
- Decided: Oct 13, 2016 after 146 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.
No later device cites it as a predicate yet.
0 of 10 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.

## Indications for use
Carilex VT:One/VT-One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days 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

Source page: https://510kreport.com/device/K161410
Methodology: https://510kreport.com/methodology