# K801862: Medela Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Oct 23, 1980 after 79 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
140 later devices descend from it; 1 cites it directly.
0 of 141 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- 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
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty (2015), 55 descendants of its own

## Recalls of this device
- Aug 6, 2010 · Not classified · Z-2485-2010: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.

Source page: https://510kreport.com/device/K801862
Methodology: https://510kreport.com/methodology