# K041636: H&S-Conductivity Standard Solution

- Pathway: 510(k) (Traditional)
- Applicant: H & S Technical Services
- Decided: Jul 2, 2004 after 15 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: 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)
- K032075: Conductivity Standard Solution-Metercare, Ibp Instruments GmbH (2003). Our OCR of the scanned summary read K032073, FDA’s number for Gore Introducer Sheath with Silicone Pinch Valve (W. L. Gore & Associates, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Conductivity Standard Solution - MeterCare”.

## Cited in the summary but kept off the family tree
- K043330: Polypropilene Surgical Sutures, Demetech Corp. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Dec 12, 2025 · Class II · Z-1185-2026: due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.

## Indications for use
"H&S - Conductivity Standard Solutions" are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters; which may include meters and cells used by the hemodialysis technician to verify or calibrate conductivity functions of dialysis related equipment. These solutions are used remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient. Conductivity Standard Solution is for In-Vitro Use Only.

Source page: https://510kreport.com/device/K041636
Methodology: https://510kreport.com/methodology