# K992431: Neo-2 Meter

- Pathway: 510(k) (Traditional)
- Applicant: Automata Instrumentation, Inc.
- Decided: Oct 13, 1999 after 84 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K020908: HDM97 (2002), 2 descendants of its own
- K020909: HDM99 (2002), 1 descendant of its own
- 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 NEO-2 Meter may be used by hemodialysis personnel to test conductivity, temperature, pressure, and pH of the dialysate solution used with hemodialysis delivery systems. The NEO-2 Meter may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodillysis applications.

Source page: https://510kreport.com/device/K992431
Methodology: https://510kreport.com/methodology