# K112856: Lucina-Melodi

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: May 10, 2012 after 223 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)
- K020518: Medela Symphony Breast Pump, Model 024, Medela, Inc. (2002) Summary page 1.
- K102516: Lucina Model Melodi, Genadyne Biotechnologies, Inc. (2011) Summary page 2.

## Indications for use
The Lucina-Melodi Advance Breast Pump is intended to express and collect milk from the breast of lactating women. This device may be used by more than one user if the collection kit is changed.

Source page: https://510kreport.com/device/K112856
Methodology: https://510kreport.com/methodology