# K081932: Endeare Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Hygeia Medical, Inc.
- Decided: Jan 22, 2009 after 199 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: 2 generations back to K875300 (1988). 4 ancestors in all.
2 later devices descend 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)
- K875300: Medela Breast-Pump Lactina, Medela, Inc. (1988) Summary page 1.
- K950750: Medelas Breast Pump, Medela, Inc. (1995) Summary page 1.
- K973501: Expresse and Premier Powered Breast Pumps, Ameda Medizintechnik AG (1997) Summary page 1.

## Most influential descendants
- K190465: Evolve Breast Pump (2019), 1 descendant of its own
- K200406: Evolve Breast Pump (2020), 0 descendants of its own

## Indications for use
The EnDeareTM Breast Pump is indicated to express and collect milk from the breasts of lactating women

Source page: https://510kreport.com/device/K081932
Methodology: https://510kreport.com/methodology