# K102516: Lucina Model Melodi

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Aug 11, 2011 after 343 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: 3 generations back to K801862 (1980). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950750: Medelas Breast Pump, Medela, Inc. (1995) Summary page 1.
- K031614: Medela Pump in Style Advanced Breast Pump, Medela, Inc. (2003) Summary page 1.

## Most influential descendants
- K143574: Melodi Prime Breast Pump (2015), 0 descendants of its own
- K112856: Lucina-Melodi (2012), 0 descendants of its own

## Indications for use
The Lucina-Melodi Powered Breast Pump is intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K102516
Methodology: https://510kreport.com/methodology