# K021368: Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: May 15, 2002 after 15 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.
119 later devices descend from it; 8 cite it directly.
0 of 120 devices in its family (counting itself) have 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
- K043544: Medela Dominant 35 C/I Secretion and Surgical Aspirator (2005), 93 descendants of its own
- K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator (2006), 85 descendants of its own
- 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

## Indications for use
The Basic 30 and Dominant 50 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/K021368
Methodology: https://510kreport.com/methodology