# K020908: HDM97

- Pathway: 510(k) (Traditional)
- Applicant: Ibp Instruments GmbH
- Decided: May 22, 2002 after 63 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: 1 generation back to K992431 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992431: Neo-2 Meter, Automata Instrumentation, Inc. (1999) Summary page 2.

## Most influential descendants
- K201765: SmartHDM-510 System (2020), 0 descendants of its own
- K043031: Serim Dialysate Monitor Test Strip (2005), 0 descendants of its own

## Indications for use
The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems. The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.

Source page: https://510kreport.com/device/K020908
Methodology: https://510kreport.com/methodology