# K113315: Rumble Tuff

- Pathway: 510(k) (Traditional)
- Applicant: Acute Ideas Co., Ltd.
- Decided: Nov 20, 2012 after 377 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). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053052: Medela Swing Breast Pump, Medela AG (2006) Summary page 1.
- K092783: DEBP, Enko, Ltd. (2009) Summary page 1.

## Most influential descendants
- K252583: Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (2026), 0 descendants of its own
- K200712: Rumble Tuff Electric Breast Pump (2020), 0 descendants of its own

## Indications for use
The Rumble Tuff Electric Breast Pump is an electrically powered single-user device to express and collect milk from the breasts of lactating women. The device is not intended for hospital use.

Source page: https://510kreport.com/device/K113315
Methodology: https://510kreport.com/methodology