# K190465: Evolve Breast Pump

- Pathway: 510(k) (Special)
- Applicant: Hygeia II Medical Group, Inc.
- Decided: Oct 18, 2019 after 234 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: 3 generations back to K875300 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081932: Endeare Breast Pump, Hygeia Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K200406: Evolve Breast Pump (2020), 0 descendants of its own

## Indications for use
The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

Source page: https://510kreport.com/device/K190465
Methodology: https://510kreport.com/methodology