# K971231: White River Mini Manual Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: White River Concepts
- Decided: May 19, 1997 after 46 days
- Product code: HGY (Pump, Breast, Non-Powered)
- Device class: 1
- Regulation: 21 CFR 884.5150
- 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 Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.

Source page: https://510kreport.com/device/K971231
Methodology: https://510kreport.com/methodology