# K964679: White River Automatic Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: White River Concepts
- Decided: Jun 10, 1997 after 201 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk. Target Population: Mothers who are breast feeding in the hospital setting.

Source page: https://510kreport.com/device/K964679
Methodology: https://510kreport.com/methodology