# K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Jun 21, 2006 after 51 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933902 (1994). 4 ancestors in all.
85 later devices descend from it; 5 cite it directly.
0 of 90 devices in its family (counting itself) have 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.
- K043544: Medela Dominant 35 C/I Secretion and Surgical Aspirator, Medela AG (2005) Summary page 1.

## Most influential descendants
- K080357: Medela Invia Wound Therapy (2008), 75 descendants of its own
- K083375: Renasys GO Negative Pressure Wound Therapy (2009), 56 descendants of its own
- K111170: PICO (2011), 26 descendants of its own
- K112127: Pico Single Use Negative Pressure Wound Therapy System (2012), 25 descendants of its own
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), 23 descendants of its own

## Recalls of this device
- Apr 25, 2008 · Not classified · Z-2168-2008: The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps 

## Indications for use
The Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patients bedside. Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and thoracic drainage (in combination with a water seal or dry seal chest drain) in either "constant" or "intermittent" mode. Especially for thoracic drainage the Medela Vario 8 is indicated in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.

Source page: https://510kreport.com/device/K061205
Methodology: https://510kreport.com/methodology