# K050812: 90XL Instrumentation System

- Pathway: 510(k) (Special)
- Applicant: Mesa Laboratories, Inc.
- Decided: May 5, 2005 after 35 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K201765: SmartHDM-510 System (2020), 0 descendants of its own

## Indications for use
The 90XL Dialysis Meter is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the 90XL instrumentation system to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and adjusting to maintain safe and effective hemodialysis systems.

Source page: https://510kreport.com/device/K050812
Methodology: https://510kreport.com/methodology