# K092783: DEBP

- Pathway: 510(k) (Traditional)
- Applicant: Enko, Ltd.
- Decided: Oct 22, 2009 after 42 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 K801862 (1980). 7 ancestors in all.
100 later devices descend from it; 3 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053052: Medela Swing Breast Pump, Medela AG (2006) Summary page 1.
- K973501: Expresse and Premier Powered Breast Pumps, Ameda Medizintechnik AG (1997) Summary page 1.

## Most influential descendants
- K122474: Lansinoh Powered Electric Breast Pump (2012), 63 descendants of its own
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty (2015), 55 descendants of its own
- K162415: Spectra 9Plus (2017), 32 descendants of its own
- K163136: Youha electric breast pump (2017), 30 descendants of its own
- K161266: Athena Breast Pump (2016), 28 descendants of its own

## Indications for use
The DEBP is intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

Source page: https://510kreport.com/device/K092783
Methodology: https://510kreport.com/methodology