510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Crit-Line Blood Chamber with E-Beam

K935958510(k) TraditionalCleared Jan 19, 1995419-day reviewClass II21 CFR 876.5820Recalls 1

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. · KOC Accessories, Blood Circuit, Hemodialysis

Cleared on Jan 19, 1995 after a 419-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it. It has been recalled once.

Decided
Jan 19, 1995
Review
419 days
Class
Class II
Product code
KOC
Recalls
1
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2025: 3 descendants cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK935958 Crit-Line Blood Chamber with E-BeamIn-Line Diagnostics Corp. · 1995
  2. Descendant · cites it directly · 7 of its ownK141281 Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care Renal Therapies Group, LLC · 2014
  3. Descendant · 2 generations on · 6 of its ownK152953 Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America · 2015
  4. Descendant · 3 generations on · 5 of its ownK201207 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached…Fresenius Medical Care Renal Therapies Group, LLC · 2020
  5. Descendant · 4 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
  6. Descendant · 4 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12020: 12023: 12024: 12025: 3
2014high 3 (2025) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all
  • K141281Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care Renal Therapies Group, LLC · 2014 · cites it directly7descendants
  • K152953Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America · 2015 · 2 generations on6descendants
  • K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Fresenius Medical Care Renal Therapies Group, LLC · 2020 · 3 generations on5descendants
  • K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 4 generations on2descendants
  • K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935958Crit-Line Blood Chamber with E-BeamIn-Line Diagnostics Corp.1995—
+1K141281Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care Renal Therapies Group, LLC2014—
+2K152953Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America2015—
+3K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and…Fresenius Medical Care Renal Therapies Group, LLC2020—
+4K2315345008X Hemodialysis SystemFresenius Medical Care20241
+4K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC20256

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
202010
202310
202410
202530
FIG. 1 — Lineage of K935958, 1995–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KOC? 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 KOC device

  1. #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141281Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care Renal Therapies Group, LLC20147

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 27, 2015Class IIZ-1716-2015Under Investigation by firmBlood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K141281 (Fresenius Medical Care Renal Therapies Group, LLC, 2014) has gone furthest, with 7 descendants of its own.

How does its category compare?

All KOC devices

KOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOC

2in 2025

2007: 12008: 22009: 22012: 12014: 12015: 22016: 12017: 12020: 12023: 22025: 2
2007high 2 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KOC

Too few KOC 510(k)s in any year since 2007 to give a median.

Recalls per year · KOC

4so far in 2026, the most since 2007

2008: 22012: 12014: 12018: 32026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KOC

50in 2025

2007: 32008: 122009: 122010: 42011: 102012: 22013: 222014: 1652015: 5552016: 102017: 232018: 372019: 562020: 202021: 332022: 262023: 162024: 182025: 50
2007high 555 (2015) · low 2 (2012)2025

MAUDE reports naming product code KOC, 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
20071—03
20082—212
20092—012
20100—04
20110—010
20121—12
20130—022
20141—1165
20152—0555
20161—010
20171—023
20180—337
20190—056
20201—020
20210—033
20220—026
20232—016
20240—018
20252—050
20260—4—

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
  • K982412Modification of Crit-Line Monitor Iii (CLM Iii)In-Line Diagnostics Corp. · 1998
  • K972470Crit-Line Monitor (Clmiii)In-Line Diagnostics Corp. · 1997

Recent decisions in KOC

The KOC category page

  • K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series…Nikkiso CO., LTD. · 2025
  • K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series…Nikkiso CO., LTD. · 2025
  • K231589Blood Tubing Lines for Hemodialysis AV06C-ENikkiso CO., LTD. · 2023
  • K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNikkiso CO., LTD. · 2023
  • K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line…Fresenius Medical Care Renal Therapies Group, LLC · 2020

https://510kreport.com/device/K935958 · printed Nov 5, 2026

Cite this page

510(k) Report. “K935958: Crit-Line Blood Chamber with E-Beam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935958

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026