# K200712: Rumble Tuff Electric Breast Pump

- Pathway: 510(k) (Special)
- Applicant: A Cute Baby, Inc.
- Decided: Apr 17, 2020 after 30 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 4.

## Indications for use
The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating Women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

Source page: https://510kreport.com/device/K200712
Methodology: https://510kreport.com/methodology