510(k) · Cleared
ClearedCrit-Line Monitor (Clmiii)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In-Line Diagnostics Corp. · MQS System, Hemodialysis, Access Recirculation Monitoring
Cleared on Dec 11, 1997 after a 163-day review. The FDA summary names its predicate without a number. 3 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Dec 11, 1997
- Review
- 163 days
- Class
- Class II
- Product code
- MQS
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- This deviceK972470 Crit-Line Monitor (Clmiii)In-Line Diagnostics Corp. · 1997
- Descendant · cites it directly · 12 of its ownK121599 Crit-Line Clip (Clic)Fresenius Medical Care-North America · 2012 · Recalled
- Descendant · 2 generations on · 10 of its ownK131908 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013
- Descendant · 3 generations on · 9 of its ownK150708 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T…Fresenius Medical Care Renal Therapies Group, LLC · 2015 · Recalled (Class I)
- Descendant · 4 generations on · 8 of its ownK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- Descendant · 5 generations on · 7 of its ownK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K121599Crit-Line Clip (Clic)Fresenius Medical Care-North America · 2012 · cites it directly12descendants
- K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013 · 2 generations on10descendants
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 3 generations on9descendants
- K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · 4 generations on8descendants
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972470 | Crit-Line Monitor (Clmiii) | In-Line Diagnostics Corp. | 1997 | — |
| +1 | K121599 | Crit-Line Clip (Clic) | Fresenius Medical Care-North America | 2012 | 1 |
| +2 | K131908 | 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) | Fresenius Medical Care Renal Therapies Group, LLC | 2013 | — |
| +3 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| +4 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 2 |
| +5 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 2 | 0 |
| 2018 | 1 | 1 |
| 2022 | 1 | 1 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
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.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQS device
- #1 K232283 PhySoftAMS®score 8.0 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Crit-Line II (Clmii) Named without a submission number |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K121599 (Fresenius Medical Care-North America, 2012) has gone furthest, with 12 descendants of its own.
How does its category compare?
All MQS devicesMQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQS
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MQS
Too few MQS 510(k)s in any year since 2007 to give a median.
Recalls per year · MQS
No recall names MQS since 2007.
Adverse event reports per year · MQS
5in 2013
MAUDE reports naming product code MQS, 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 | 68 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (162 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972470: Crit-Line Monitor (Clmiii).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972470
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026