# K100237: Dialysate Meter, Model D-6

- Pathway: 510(k) (Traditional)
- Applicant: Myron L Company
- Decided: Apr 23, 2010 after 87 days
- Product code: FLB (Meter, Conductivity, Induction, Remote Type)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hydra: named in the summary without a submission number
- (no number) 90XL: named in the summary without a submission number
- (no number) HDM97: named in the summary without a submission number

## Indications for use
Myron L Company D-6 Dialysate MeterTM is a hand-held, multi-test instrument that is intended for use by trained hemodialysis professionals to verify the characteristics of product water, dialysate and sodium bicarbonate dialysate used with hemodialysis systems as a means of independently verifying functioning of in-line monitors. It may also be used by water purification specialist to verify the suitability of feed water used with hemodialysis systems and to test wastewater created by hemodialysis systems. D-6 Dialysate Meter is intended for the above uses where: * The measurement of conductivity, resistivity, TDS, pH is needed and; * The measurement of Oxidation Reduction Potential (ORP) is needed to determine the presence and level of reducing agents in source water, product water and/or treated wastewater

Source page: https://510kreport.com/device/K100237
Methodology: https://510kreport.com/methodology