# K983552: Basic, Median, Dominant, and Vario

- Pathway: 510(k) (Abbreviated)
- Applicant: Medela, Inc.
- Decided: Jan 7, 1999 after 90 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
No predicates in its family tree.
187 later devices descend from it; 9 cite it directly.
1 of 188 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042134: Versatile 1 Wound Vacuum System (2004), 159 descendants of its own
- K052456: Modification to Versatile 1 Wound Vacuum System (2005), 127 descendants of its own
- K061435: Medela Vario Suction Pumps (2006), 120 descendants of its own
- K070904: Antlia II Suction Pump System (2007), 109 descendants of its own
- K061919: Versatile 1 Ezcare Wound Vacuum System (2007), 107 descendants of its own

## Indications for use
The Basic, Median, Dominant and Vario Suction Pumps are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient’s airway or respiratory support system, either during surgery or at the patient’s bedside.

Source page: https://510kreport.com/device/K983552
Methodology: https://510kreport.com/methodology