# K972470: Crit-Line Monitor (Clmiii)

- Pathway: 510(k) (Traditional)
- Applicant: In-Line Diagnostics Corp.
- Decided: Dec 11, 1997 after 163 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
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
3 of 17 devices 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) Crit-Line II (Clmii): named in the summary without a submission number

## Most influential descendants
- K121599: Crit-Line Clip (Clic) (2012), 12 descendants of its own
- K131908: 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) (2013), 10 descendants of its own
- K150708: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (2015), 9 descendants of its own
- K153449: 2008K2 Hemodialysis Machine (2016), 8 descendants of its own
- K173972: 2008T BlueStar Hemodialysis Machine (2018), 7 descendants of its own

## Indications for use
The family of CRIT-LINE Monitors (CLM’s), include the CLM 11 (predicate device) and the CLM III. These devices are used to non-invasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

Source page: https://510kreport.com/device/K972470
Methodology: https://510kreport.com/methodology