Hydra Meter
by Automata Instrumentation, Inc.
510(k) K974127
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974127 | Date19 Dec 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FIP
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5665
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hydra Meter is a handheld, multi-function instrument designed as a subsystem for water purification. It measures key water parameters, including conductivity, resistivity, total dissolved solids (TDS), pH, and temperature, to ensure water quality for specialized applications such as hemodialysis.
This device is intended for use by water purification specialists in controlled settings and is supplied as a reusable instrument. It is classified under FDA product code FIP (Water Purification) and has received FDA 510(k) clearance (K974127) as substantially equivalent to a predicate device. The Hydra Meter operates in non-sterile environments and is regulated under the U.S. Food, Drug, and Cosmetic Act, specifically under regulation number 876.5665.
Other devices from Automata Medical Instrumentation, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Hydra Meter used for?
The Hydra Meter is a handheld, multi-function instrument designed as a subsystem for water purification. It measures critical water parameters—conductivity, resistivity, total dissolved solids (TDS), pH, and temperature—to ensure water quality for specialized applications, particularly in hemodialysis systems. This ensures safe and reliable water treatment in controlled environments.
Is the Hydra Meter reusable or single-use?
The Hydra Meter is supplied as a reusable instrument. It is intended for use by water purification specialists in controlled settings, where it can be cleaned and maintained for repeated use. Reusability is a key feature for cost-effective monitoring in specialized water treatment applications.
Does the Hydra Meter require sterile conditions for operation?
No, the Hydra Meter is designed for use in non-sterile environments. While it ensures water quality for applications like hemodialysis, the device itself does not need to be sterile during operation. Proper cleaning and maintenance protocols are recommended to sustain its performance and accuracy.
What regulatory approval does the Hydra Meter hold?
The Hydra Meter has received FDA 510(k) clearance (K974127) under the U.S. Food, Drug, and Cosmetic Act. It is classified under FDA product code FIP (Water Purification) and is regulated under regulation number 876.5665. This clearance confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. medical device regulations.
What parameters does the Hydra Meter measure?
The Hydra Meter measures five key water parameters: conductivity, resistivity, total dissolved solids (TDS), pH, and temperature. These measurements are essential for assessing water quality in specialized applications, such as hemodialysis, where precise water purity is critical for patient safety and equipment performance.