# K033330: Conductivity/TDS Calibrator Solution

- Pathway: 510(k) (Traditional)
- Applicant: Mesa Laboratories, Inc.
- Decided: Feb 27, 2004 after 134 days
- Product code: FKH (Solution-Test Standard-Conductivity, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851362 (1985). 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)
- K851362: Standard Solution of Conductivity & Measurement of, Rna Medical Corp. (1985) Summary page 1.

## Most influential descendants
- K191496: TDS Standard Solution (2019), 0 descendants of its own
- K130100: Comined Standard Solution (2013), 0 descendants of its own

## Recalls of this device
- May 12, 2017 · Class II · Z-2159-2017: Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.

## Indications for use
Conductivity/TDS Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity 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 do not come into contact with the patient.

Source page: https://510kreport.com/device/K033330
Methodology: https://510kreport.com/methodology