# K011741: Crit-Line Monitor Iii Tqa (CLM Tqa)

- Pathway: 510(k) (Traditional)
- Applicant: Hemametrics
- Decided: Jul 23, 2002 after 413 days
- Product code: FIL (System, Dialysate Delivery, Single Pass)
- 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.
5 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has 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) EktaChem DT60 (Vitros DT60 Chemistry System): named in the summary without a submission number

## 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 intended use of the CRIT-LINE I11 TQA Monitor is as a non-invasive hematocrit, oxygen saturation, and percent change in blood volume monitor. The CRIT-LINE I11 TQA Monitor also non-invasively estimates access recirculation and non-invasively estimates access blood flow. In addition, the CLM I11 TQA Monitor calculates an estimated Urea Reduction Ratio based on relative changes in urea nitrogen concentration in the spent dialysate.

Source page: https://510kreport.com/device/K011741
Methodology: https://510kreport.com/methodology