# K043544: Medela Dominant 35 C/I Secretion and Surgical Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Jan 7, 2005 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
Longest line of descent: 1 generation back to K933902 (1994). 2 ancestors in all.
93 later devices descend from it; 3 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021368: Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057, Medela AG (2002) Summary page 1.
- K933902: Moblvac Iii, Aeros Instruments, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K112127: Pico Single Use Negative Pressure Wound Therapy System (2012), 25 descendants of its own

## Indications for use
The Dominant 35 c/i Suction Pump is indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patients bedside. Generally the Dominant 35 c/i is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal, wound and thoracic drainage (must be used only in combination with a chest drainage unit with a built inflow adjustment valve) in either "constant" or "intermittent" mode.

Source page: https://510kreport.com/device/K043544
Methodology: https://510kreport.com/methodology