# K992227: Crit-Line Monitor Iii (CLM Iii)

- Pathway: 510(k) (Special)
- Applicant: In-Line Diagnostics Corp.
- Decided: Jul 30, 1999 after 28 days
- Product code: MQS (System, Hemodialysis, Access Recirculation Monitoring)
- 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 K960817 (1997). 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)
- K982412: Modification of Crit-Line Monitor Iii (CLM Iii), In-Line Diagnostics Corp. (1998) Summary page 1.

## Indications for use
The CRIT-LINE MONITOR 111, (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM II estimates access recirculation and access blood flow in hemodialysis patients.

Source page: https://510kreport.com/device/K992227
Methodology: https://510kreport.com/methodology