510(k) · Cleared
ClearedCrit-Line Monitor Iii (CLM Iii)
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 Jul 30, 1999 as substantially equivalent to K982412 (In-Line Diagnostics Corp., 1998) after a 28-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 30, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- MQS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960817 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
- 1 generation backK982412 Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1998
- This deviceK992227 Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | 1 |
| −1 | K982412 | Modification of Crit-Line Monitor Iii (CLM Iii) | In-Line Diagnostics Corp. | 1998 | — |
| 0 (this device) | K992227 | Crit-Line Monitor Iii (CLM Iii) | In-Line Diagnostics Corp. | 1999 | — |
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.
Planning a device in MQS? 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 |
|---|---|---|---|
| * | K982412 | Modification of Crit-Line Monitor Iii (CLM Iii)Summary page 1…e (i.e. calculator, ‘ spreadsheet etc.) in order to obtain an Access Blood Flow value. The 510 (k) # for the external source method of determining Access Blood Flow is K982412. IN-LINE DIAGNOSTICS CORPORATION * 117 WEST 200 Sou‘rlg PO. dB Kxig INP‘gJN, Utan 84025-0685 « (801) 451-9000 Fax (801) 451-9067… | 1998 |
| † | K972470 | Crit-Line Monitor (Clmiii) | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K982412.
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 CRIT-LINE MONITOR 111, (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 II estimates access recirculation and access blood flow in hemodialysis patients.
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/K992227 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992227: Crit-Line Monitor Iii (CLM Iii).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992227
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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