# K112458: Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System

- Pathway: 510(k) (Special)
- Applicant: Medica-Rents Co., Ltd.
- Decided: Jan 5, 2012 after 132 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: 3 generations back to K945062 (1995). 7 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 23 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.

## Most influential descendants
- K113291: Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300 (2012), 4 descendants of its own
- K162159: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (2017), 3 descendants of its own
- K141255: Simex Subglottic Aspiration System (2014), 3 descendants of its own
- K112853: Voltera Powered Suction Pump (2012), 3 descendants of its own
- K150157: AnapnoGuard 100 Respiratory Guard System (2016), 2 descendants of its own

## Indications for use
The Prospera Negative Pressure Wound Therapy System is indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. The Prospera Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside and is indicated for home use.

Source page: https://510kreport.com/device/K112458
Methodology: https://510kreport.com/methodology