# K252583: Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)

- Pathway: 510(k) (Abbreviated)
- Applicant: A Cute Baby, Inc.
- Decided: Mar 12, 2026 after 209 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: 5 generations back to K801862 (1980). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113315: Rumble Tuff, Acute Ideas Co., Ltd. (2012) Summary page 5.

## Indications for use
The Moon Wave (PA220) and Mini Moon (PA221) Electric Breast Pump is a personal use, electrically powered device used to express milk from the breasts of lactating women. This device is not intended for hospital use.

Source page: https://510kreport.com/device/K252583
Methodology: https://510kreport.com/methodology