# K062456: Novaspine Powered Suction Pump Pro-1

- Pathway: 510(k) (Traditional)
- Applicant: Novaspine, LLC
- Decided: Oct 16, 2006 after 54 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: 2 generations back to K945062 (1995). 6 ancestors in all.
16 later devices descend from it; 3 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)
- K971548: Ambuvac, Kinetic Concepts, Inc. (1997) Summary page 1.
- K042134: Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2004) Summary page 1.
- K061133: Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S, Novaspine, LLC (2006) Summary page 1.

## Most influential descendants
- K112458: Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System (2012), 15 descendants of its own
- 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

## Indications for use
The NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.

Source page: https://510kreport.com/device/K062456
Methodology: https://510kreport.com/methodology