# K191653: Freestyle Flex

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Oct 17, 2019 after 119 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: 6 generations back to K801862 (1980). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty, Medela AG (2015) Summary page 4.

## Most influential descendants
- K212773: ARDO Alyssa (2022), 1 descendant of its own
- K210759: Solo, Swing Maxi (2021), 1 descendant of its own
- K232608: Duo Hands-free Breast Pump (2024), 0 descendants of its own
- K230590: ARDO Bellis (2023), 0 descendants of its own

## Indications for use
The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Freestyle Flex™ breast pump is intended for a single user. The breast pump is intended to be used in a home environment.

Source page: https://510kreport.com/device/K191653
Methodology: https://510kreport.com/methodology