# K213311: Lucy Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Willow Innovations, Inc.
- Decided: Feb 9, 2022 after 128 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). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200508: Pump In Style, Medela, LLC (2020) Summary page 4.

## Most influential descendants
- K243508: Wearable breast pump (model S12A) (2025), 1 descendant of its own
- K261025: Wearable breast pump (QY-101, QY-102, QY-108) (2026), 0 descendants of its own
- K253149: Motion InBra (YM-8801) wearable breast pump (2026), 0 descendants of its own
- K250350: Thrive 2-in-1 Breast Pump (Model P3) (2025), 0 descendants of its own

## Indications for use
The Lucy Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Lucy Breast Pump is intended for a single user.

Source page: https://510kreport.com/device/K213311
Methodology: https://510kreport.com/methodology