# K061435: Medela Vario Suction Pumps

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Jun 8, 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945062 (1995). 3 ancestors in all.
120 later devices descend from it; 3 cite it directly.
1 of 124 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983552: Basic, Median, Dominant, and Vario, Medela, Inc. (1999) Summary page 1.
- K042134: Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2004) Summary page 1.

## Most influential descendants
- K070904: Antlia II Suction Pump System (2007), 109 descendants of its own
- K082211: Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits (2008), 68 descendants of its own
- K083375: Renasys GO Negative Pressure Wound Therapy (2009), 56 descendants of its own
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys (2011), 48 descendants of its own
- K092992: A4-XLR8 Foam Dressing (2010), 31 descendants of its own

## Indications for use
The Medela Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's air-way or respiratory support system, either during surgery or at the patient's bedside. The Medela Vario 18 cli Suction Pump is indicated for patients who would benefit from a suctior device particularly as the device may promote wound healing. The device is also indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (includin~ vomit) 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/K061435
Methodology: https://510kreport.com/methodology