# K020518: Medela Symphony Breast Pump, Model 024

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Mar 7, 2002 after 16 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801862 (1980). 2 ancestors in all.
139 later devices descend from it; 6 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801862: Medela Electric Breast Pump, Medela, Inc. (1980) Summary page 1.
- K950531: Egnell Elite, Hollister, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K162415: Spectra 9Plus (2017), 32 descendants of its own

## Recalls of this device
- Aug 6, 2010 · Not classified · Z-2484-2010: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
- Aug 6, 2010 · Not classified · Z-2483-2010: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
- Mar 15, 2010 · Not classified · Z-1442-2010: The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.

## Indications for use
The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.

Source page: https://510kreport.com/device/K020518
Methodology: https://510kreport.com/methodology