# K112853: Voltera Powered Suction Pump

- Pathway: 510(k) (Traditional)
- Applicant: Suzric Enterprise Co., Ltd.
- Decided: Nov 9, 2012 after 407 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.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062456: Novaspine Powered Suction Pump Pro-1, Novaspine, LLC (2006) Summary page 1.
- K112458: Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System, Medica-Rents Co., Ltd. (2012). Cleared while this submission was under review Summary page 3.

## Most influential descendants
- K173407: VT - 100, VT - 200 (2018), 1 descendant of its own
- K231646: Carilex VT¿200-i NX (2024), 0 descendants of its own
- K161410: VT·One, VT·One 60days (2016), 0 descendants of its own

## Indications for use
The VOLTERA Powered Suction Pump, S1001-3 Series 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 VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts.

Source page: https://510kreport.com/device/K112853
Methodology: https://510kreport.com/methodology