# K143574: Melodi Prime Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Apr 21, 2015 after 125 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: 4 generations back to K801862 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102516: Lucina Model Melodi, Genadyne Biotechnologies, Inc. (2011) Summary page 4.

## Indications for use
The powered Melodi Prime Breast Pump is intended to express and collect milk from the breast of a lactating woman. This device is a double pump with a single pumping option; it is intended for a single user.

Source page: https://510kreport.com/device/K143574
Methodology: https://510kreport.com/methodology