# K230570: Willow Generation 3 Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Willow Innovations, Inc.
- Decided: Oct 16, 2023 after 229 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: 8 generations back to K801862 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191577: Willow Wearable Breast Pump 2.0, Exploramed Nc7, Inc. (2019) Summary page 5.

## Indications for use
The Willow® Generation 3 Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.

Source page: https://510kreport.com/device/K230570
Methodology: https://510kreport.com/methodology