# K150134: Basic, Dominant Flex, KV-6

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Apr 21, 2015 after 90 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K895761 (1989). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130123: Basic and Dominant Flex Suction Pumps, Medela AG (2013) Summary page 6.
- K063336: Medela Dominant 50 Lipo, Model 600-5706, Medela AG (2007) Summary page 6.
- K051749: Cobra Surgical System, Estech, Inc. (2005) Summary page 6.
- (no number) Octopus Evolution AS 2010: named in the summary without a submission number
- (no number) Urchin Evo Stabilizer: named in the summary without a submission number

## Most influential descendants
- K160950: Miniscav (2017), 0 descendants of its own
- K170329: Basic, Dominant Flex (2017), 0 descendants of its own

## Indications for use
The Basic Suction Pump is indicated for vacuum extraction, aspiration during flexible endoscopy, and 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 bedside. The Basic Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes. The Dominant Flex Suction Pump is indicated for vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, and 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 bedside. The Dominant Flex Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes.

Source page: https://510kreport.com/device/K150134
Methodology: https://510kreport.com/methodology