510(k) Report

510(k) · Cleared

Cleared

Modification of Crit-Line Monitor Iii (CLM Iii)

K982412510(k) TraditionalCleared Oct 9, 199888-day reviewClass II21 CFR 876.5820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

In-Line Diagnostics Corp. · MQS System, Hemodialysis, Access Recirculation Monitoring

Cleared on Oct 9, 1998 as substantially equivalent to K960817 (Transonic Systems, Inc., 1997) after an 88-day review. Its family tree reaches back 1 generation to 1997. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.

Decided
Oct 9, 1998
Review
88 days
Class
Class II
Product code
MQS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K960817 (1997). 6 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1999: 1 descendant cleared2006: 2 descendants cleared2007: 2 descendants cleared2020: 1 descendant cleared, 1 with a Class I recall1K960817 · HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) · Transonic Systems, Inc. · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant, 1 with a Class I recall1 K960817 · HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) · Transonic Systems, Inc. · 1997 · recalled0+5
  1. Root · 1 generation backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
  2. This deviceK982412 Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1998
  3. Descendant · cites it directly · 4 of its ownK060008 Aquadex Flexflow SystemChf Solutions, Inc. · 2006
  4. Descendant · 2 generations on · 3 of its ownK062922 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2006
  5. Descendant · 3 generations on · 2 of its ownK070512 Modification to Aquadex Flexflow SystemChf Solutions, Inc. · 2007
  6. Descendant · 4 generations on · 1 of its ownK071854 Aquadex Flexflow SystemChf Solutions, Inc. · 2007
  7. Descendant · 5 generations on · 0 of its ownK192756 Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · Recalled (Class I)

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999: 12006: 22007: 22020: 1
1999high 2 (2006) · low 0 (2000)2026

Class I recalls in this family

  • K192756 Aquadex FlexFlow System 2.05 generations on · 2020

Most influential descendants

Showing 5 of 6 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K960817HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc.19971
0 (this device)K982412Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp.1998—
+1K060008Aquadex Flexflow SystemChf Solutions, Inc.2006—
+2K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc.2006—
+3K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc.2007—
+4K071854Aquadex Flexflow SystemChf Solutions, Inc.2007—
+5K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc.2020Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200620
200720
202011
FIG. 1 — Lineage of K982412, 1997–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Top candidate predicates for a new MQS device

  1. #1 K232283 PhySoftAMS®score 8.0 · 6 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K960817HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)
Summary page 1
…een calculated from of the hematocrit data measured by the CLM III, have been found to be substantially equivalent to the values measured by the Transonic HDO1 Monitor (#K960817) which is currently being marketed by Transonic Systems, Inc. IN-LINE DIAGNOSTICS CORPORATION » 117 WEST 200 SourAPpendick SePag…
Transonic Systems, Inc.19971

Also cleared against K960817: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060008Aquadex Flexflow SystemChf Solutions, Inc.20064
K992227Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp.19990

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?

  • Its one ancestor has a recall.
  • Of its descendants, K060008 (Chf Solutions, Inc., 2006) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K960817.

How does its category compare?

All MQS devices

MQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQS

1in 2023

2013: 12019: 12023: 1
2007high 1 (2013) · low 0 (2007)2026

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

2007: 682008: 62009: 212010: 102011: 12012: 52013: 5
2007high 68 (2007) · low 0 (2014)2025

MAUDE reports naming product code MQS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—068
20080—06
20090—021
20100—010
20110—01
20120—05
20131—05
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K960817

3 other devices cite the same predicate.

  • K134051Transonic Elsa SystemTransonic Systems, Inc. · 2015
  • K030456Vasc-AlertVasc-Alert, LLC · 2003
  • K980906Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998

More from In-Line Diagnostics Corp.

8 FDA decisions under this applicant name. See the company

  • K001763Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 2000
  • K992227Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1999
  • K983551Crit-Scan II MonitorIn-Line Diagnostics Corp. · 1999
  • K972470Crit-Line Monitor (Clmiii)In-Line Diagnostics Corp. · 1997
  • K953875Crit-Line Hematocrit Alert (Modification)In-Line Diagnostics Corp. · 1996

Recent decisions in MQS

The MQS category page

  • K232283PhySoftAMS®Physician Software Systems, LLC · 2023
  • K180410Dosis SAMDosis, Inc. · 2019
  • K130579Physoft AmsPhysicians Software Systems, LLC · 2013
  • K042566Vasc-AlertVasc-Alert, Inc. · 2004
  • K022963Transonic Syringe Warmer, Model Syr-1000Transonic Systems, Inc. · 2002

https://510kreport.com/device/K982412 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982412: Modification of 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/K982412

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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