# K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Apr 21, 2015 after 54 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: 5 generations back to K801862 (1980). 9 ancestors in all.
55 later devices descend from it; 6 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122474: Lansinoh Powered Electric Breast Pump, Lansinoh Laboratories Saglik Gerecleri Tasarim San (2012) Summary page 5.

## Most influential descendants
- K161266: Athena Breast Pump (2016), 28 descendants of its own
- K191577: Willow Wearable Breast Pump 2.0 (2019), 27 descendants of its own
- K212180: Wearable Breast Pump (Model S12) (2022), 25 descendants of its own
- K181863: Elvie Pump (2018), 10 descendants of its own
- K242850: Wearable breast pump (model W8) (2025), 8 descendants of its own

## Indications for use
The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.

Source page: https://510kreport.com/device/K150499
Methodology: https://510kreport.com/methodology