# K061788: Boehringer Laboratories Suction Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Laboratories
- Decided: Jul 11, 2006 after 15 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945062 (1995). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060277: Boehringer Laboratories Suction Pump System, Boehringer Laboratories (2006) Summary page 1.
- K042134: Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2004) Summary page 1.
- K052456: Modification to Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2005) Summary page 1.

## Most influential descendants
- K080897: Venturi Negative Pressure Wound Therapy System (2008), 4 descendants of its own
- K151263: Venturi Gauze Wound Care Sets with Portal Drain (2016), 1 descendant of its own
- K161948: Avance Gauze Dressing Kits (2016), 0 descendants of its own
- K161797: Avance Tubing, Avance Y-Connector, Avance ViewPad (2016), 0 descendants of its own
- K143004: VENTURI MiNO TG600/14 (2016), 0 descendants of its own

## Recalls of this device
- Jul 9, 2010 · Not classified · Z-2609-2010: Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity.
- Jul 29, 2009 · Not classified · Z-2044-2009: Labeling: The expiration date does not appear on the product label.
- Jul 29, 2009 · Not classified · Z-2043-2009: Labeling: The expiration date does not appear on the product label.
- Jul 29, 2009 · Not classified · Z-2045-2009: Labeling: The expiration date does not appear on the product label.
- Jul 13, 2009 · Not classified · Z-1814-2009: Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.

## Indications for use
The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation flUids, body fluids and infectious materials.

Source page: https://510kreport.com/device/K061788
Methodology: https://510kreport.com/methodology