# K982412: Modification of Crit-Line Monitor Iii (CLM Iii)

- Pathway: 510(k) (Traditional)
- Applicant: In-Line Diagnostics Corp.
- Decided: Oct 9, 1998 after 88 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: 1 generation back to K960817 (1997). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960817: HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2), Transonic Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K060008: Aquadex Flexflow System (2006), 4 descendants of its own
- K062922: Modification to Aquadex Flexflow System (2006), 3 descendants of its own
- K070512: Modification to Aquadex Flexflow System (2007), 2 descendants of its own
- K071854: Aquadex Flexflow System (2007), 1 descendant of its own
- K192756: Aquadex FlexFlow System 2.0 (2020), 0 descendants of its own

## Indications for use
The CRIT-LINE MONITOR I1I, (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 III estimates access recirculation and access blood flow in hemodialysis patients.

Source page: https://510kreport.com/device/K982412
Methodology: https://510kreport.com/methodology