# K250129: AViTA Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Jun 11, 2026 after 510 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)
- K201381: Philips Avent Single/Double electric breast pump Advanced, Philips Consumer Lifestyle - Innovation Site Eindhoven (2020) Summary page 5.

## Indications for use
The AViTA Breast Pump is intended to express and collect milk from the breasts of lactating women, and to alleviate engorgement of the breast. The device is intended for a single user.

Source page: https://510kreport.com/device/K250129
Methodology: https://510kreport.com/methodology