# K153663: Vario 8/18/ci

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: May 18, 2016 after 149 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- 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: 3 generations back to K945062 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator, Medela AG (2006) Summary page 5.
- K061435: Medela Vario Suction Pumps, Medela AG (2006) Summary page 5.

## Most influential descendants
- K221676: Exsalta (2022), 0 descendants of its own

## 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 patient’s bed-side. Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode.

Source page: https://510kreport.com/device/K153663
Methodology: https://510kreport.com/methodology