# K974127: Hydra Meter

- Pathway: 510(k) (Traditional)
- Applicant: Automata Instrumentation, Inc.
- Decided: Dec 19, 1997 after 46 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- 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 HYDRA Meter is a hand-held, multi-test instrument intended for use by water purification specialists to measure the conductivity, resistivity, total dissolved solids (TDS), pH, and temperature of water used in hemodialysis. The HYDRA Meter may also be used to verify proper functioning of the water system’s in-line conductivity, resistivity and pH meters.

Source page: https://510kreport.com/device/K974127
Methodology: https://510kreport.com/methodology