510(k) · Cleared
ClearedCrit-Line Monitor Iii Tqa (CLM Tqa)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemametrics · FIL System, Dialysate Delivery, Single Pass
Cleared on Jul 23, 2002 after a 413-day review. The FDA summary names its predicate without a number. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jul 23, 2002
- Review
- 413 days
- Class
- Class II
- Product code
- FIL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK011741 Crit-Line Monitor Iii Tqa (CLM Tqa)Hemametrics · 2002
- Descendant · cites it directly · 4 of its ownK060008 Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK062922 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK070512 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007
- Descendant · 4 generations on · 1 of its ownK071854 Aquadex Flexflow SystemChf Solutions, Inc. · 2007
- Descendant · 5 generations on · 0 of its ownK192756 Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · Recalled (Class I)
Class I recalls in this family
- K192756 Aquadex FlexFlow System 2.05 generations on · 2020
Most influential descendants
Showing 5 of 5 · See all- K060008Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · cites it directly4descendants
- K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006 · 2 generations on3descendants
- K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007 · 3 generations on2descendants
- K071854Aquadex Flexflow SystemChf Solutions, Inc. · 2007 · 4 generations on1descendant
- K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011741 | Crit-Line Monitor Iii Tqa (CLM Tqa) | Hemametrics | 2002 | — |
| +1 | K060008 | Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +2 | K062922 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2006 | — |
| +3 | K070512 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
| +4 | K071854 | Aquadex Flexflow System | Chf Solutions, Inc. | 2007 | — |
| +5 | K192756 | Aquadex FlexFlow System 2.0 | Chf Solutions, Inc. | 2020 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2020 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | EktaChem DT60 (Vitros DT60 Chemistry System) Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060008 | Aquadex Flexflow System | 2006 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K060008 (Chf Solutions, Inc., 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FIL devicesFIL System, Dialysate Delivery, Single Pass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIL
FDA has decided no FIL device since 2007.
Median 510(k) review, days · FIL
Too few FIL 510(k)s in any year since 2007 to give a median.
Recalls per year · FIL
No recall names FIL since 2007.
Adverse event reports per year · FIL
2in 2009
MAUDE reports naming product code FIL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K011741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011741: Crit-Line Monitor Iii Tqa (CLM Tqa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011741
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026