# K210759: Solo, Swing Maxi

- Pathway: 510(k) (Traditional)
- Applicant: Medela, LLC
- Decided: Aug 11, 2021 after 149 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K801862 (1980). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191653: Freestyle Flex, Medela AG (2019) Summary page 4.

## Most influential descendants
- K232608: Duo Hands-free Breast Pump (2024), 0 descendants of its own

## Indications for use
The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts. The Solo™ / Swing Maxi™ breast pumps are intended for a single user. The breast pumps are intended to be used in a home environment.

Source page: https://510kreport.com/device/K210759
Methodology: https://510kreport.com/methodology