# K130100: Comined Standard Solution

- Pathway: 510(k) (Traditional)
- Applicant: Mesa Laboratories, Inc.
- Decided: Apr 18, 2013 after 93 days
- Product code: FKH (Solution-Test Standard-Conductivity, Dialysis)
- 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 K851362 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033330: Conductivity/TDS Calibrator Solution, Mesa Laboratories, Inc. (2004) Summary page 1.

## Indications for use
Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity and pH measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and does not come into contact with the patient.

Source page: https://510kreport.com/device/K130100
Methodology: https://510kreport.com/methodology