# K201765: SmartHDM-510 System

- Pathway: 510(k) (Special)
- Applicant: Mesa Laboratories, Inc.
- Decided: Sep 2, 2020 after 65 days
- Product code: FIZ (Meter, Conductivity, Non-Remote)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992431 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020909: HDM99, Ibp Instruments GmbH (2002) Summary page 4.
- K020908: HDM97, Ibp Instruments GmbH (2002) Summary page 4.
- K050812: 90XL Instrumentation System, Mesa Laboratories, Inc. (2005) Summary page 4.

## Indications for use
The SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pressure, pH and flow of the dialysate solution used with hemodialysis delivering systems. The SmartHDM-510 system may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications. The intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.

Source page: https://510kreport.com/device/K201765
Methodology: https://510kreport.com/methodology