# K130349: Freemie Breast Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Dao Health
- Decided: Sep 6, 2013 after 206 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111411: Freemie (R), Dao Health (2012) Summary page 2.
- K031614: Medela Pump in Style Advanced Breast Pump, Medela, Inc. (2003) Summary page 1.

## Most influential descendants
- K170722: Moxxly Flow Collection System (2017), 0 descendants of its own

## Indications for use
The Freemie breast pump collection system is intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk.

Source page: https://510kreport.com/device/K130349
Methodology: https://510kreport.com/methodology