# K970488: Hydrocheck Micro Filter

- Pathway: 510(k) (Traditional)
- Applicant: White River Concepts
- Decided: Nov 4, 1997 after 267 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 Hydrocheck Micro Filter is designed to remove particulate matter and prevent the passage of breast milk in vacuum lines and vacuum controlled breast pumps.

Source page: https://510kreport.com/device/K970488
Methodology: https://510kreport.com/methodology