# K950531: Egnell Elite

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Sep 22, 1995 after 227 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
No predicates in its family tree.
186 later devices descend from it; 5 cite it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973501: Expresse and Premier Powered Breast Pumps (1997), 148 descendants of its own
- K020518: Medela Symphony Breast Pump, Model 024 (2002), 139 descendants of its own
- K053052: Medela Swing Breast Pump (2006), 105 descendants of its own
- K092783: DEBP (2009), 100 descendants of its own
- K122474: Lansinoh Powered Electric Breast Pump (2012), 63 descendants of its own

Source page: https://510kreport.com/device/K950531
Methodology: https://510kreport.com/methodology