# K212955: Fit Pro Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Hygeia II Medical Group, Inc.
- Decided: Mar 15, 2022 after 180 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: 7 generations back to K850705 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203570: Mya Joy PLUS Breast Pump, Ameda, Inc. (2021) Summary page 4.

## Indications for use
The FIT Pro Breast Pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K212955
Methodology: https://510kreport.com/methodology