# K163183: Yooeehouse Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Nantong Poly Technology Co., Ltd.
- Decided: Oct 2, 2017 after 322 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141742: Ardo Carum and Calypso Powered Breast Pumps, Ardo Medical AG (2014) Summary page 4.

## Indications for use
The Yooeehouse breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. The Yooeehouse pumpset should be used in combination with Yooeehouse breast pump and is intended to be used by lactating women to express and collect milk from their breast. The pumpset can be used both as a single pumpset and as a double pumpset.

Source page: https://510kreport.com/device/K163183
Methodology: https://510kreport.com/methodology