# K232608: Duo Hands-free Breast Pump

- Pathway: 510(k) (Special)
- Applicant: Medela, LLC
- Decided: Apr 12, 2024 after 228 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)
- K210759: Solo, Swing Maxi, Medela, LLC (2021) Summary page 5.

## Indications for use
The Duo Hands-free breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Duo Hands-free 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/K232608
Methodology: https://510kreport.com/methodology