# K113291: Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300

- Pathway: 510(k) (Traditional)
- Applicant: Simex Medizintechnik GmbH
- Decided: Aug 30, 2012 after 296 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). 15 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K062456: Novaspine Powered Suction Pump Pro-1, Novaspine, LLC (2006) Summary page 1.
- K971548: Ambuvac, Kinetic Concepts, Inc. (1997) Summary page 1.
- K080357: Medela Invia Wound Therapy, Medela AG (2008) Summary page 1.
- K042134: Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2004) Summary page 1.

## Most influential descendants
- K141255: Simex Subglottic Aspiration System (2014), 3 descendants of its own
- K150157: AnapnoGuard 100 Respiratory Guard System (2016), 2 descendants of its own
- K180991: AG 100s (2018), 1 descendant of its own
- K221477: AG100s (2022), 0 descendants of its own

## Indications for use
The SIMEX 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 SIM EX200 and SIM EX300 Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside.

Source page: https://510kreport.com/device/K113291
Methodology: https://510kreport.com/methodology