# K111411: Freemie (R)

- Pathway: 510(k) (Traditional)
- Applicant: Dao Health
- Decided: Feb 1, 2012 after 257 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). 6 ancestors in all.
2 later devices descend 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)
- K031614: Medela Pump in Style Advanced Breast Pump, Medela, Inc. (2003) Summary page 1.
- K082802: Mipump Single Electric/Battery Breat Pump & Mipump Double Electric/Battery Breast Pump & Mipump Deluxe Double Electric/B, Learning Curve Brands Inc. the First Years (2008) Summary page 1.

## Most influential descendants
- K130349: Freemie Breast Collection System (2013), 1 descendant of its own
- K170722: Moxxly Flow Collection System (2017), 0 descendants of its own

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

Source page: https://510kreport.com/device/K111411
Methodology: https://510kreport.com/methodology