510(k) · Cleared
ClearedCrit-Line Clip (Clic) Blood Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Aug 14, 2014 as substantially equivalent to K935958 (In-Line Diagnostics Corp., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it.
- Decided
- Aug 14, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935958 (1995). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK935958 Crit-Line Blood Chamber with E-BeamIn-Line Diagnostics Corp. · 1995 · Recalled
- This deviceK141281 Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care Renal Therapies Group, LLC · 2014
- Descendant · cites it directly · 6 of its ownK152953 Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America · 2015
- Descendant · 2 generations on · 5 of its ownK201207 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached…Fresenius Medical Care Renal Therapies Group, LLC · 2020
- Descendant · 3 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · 3 generations on · 1 of its ownK213992 CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152953Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America · 2015 · cites it directly6descendants
- K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Fresenius Medical Care Renal Therapies Group, LLC · 2020 · 2 generations on5descendants
- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 3 generations on2descendants
- K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
- K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935958 | Crit-Line Blood Chamber with E-Beam | In-Line Diagnostics Corp. | 1995 | 1 |
| 0 (this device) | K141281 | Crit-Line Clip (Clic) Blood Chamber | Fresenius Medical Care Renal Therapies Group, LLC | 2014 | — |
| +1 | K152953 | Crit-Line Clip (Clic) Blood Chamber | Fresenius Medical Care North America | 2015 | — |
| +2 | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and… | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
| +3 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
| +3 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| +3 | K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
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 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K935958 | Crit-Line Blood Chamber with E-BeamSummary page 4…ology-Urology Classification Name: Accessories, Blood Circuit, Hemodialysis Regulation: 21 CFR 876.5820 5.3. Legally Marketed Predicate Device CRIT-LINE Blood Chamber (K935958) 5.4. Device Description The CRIT LINE™ Clip (CLiC) Blood Chamber is a non-invasive, disposable, transparent optical cuvette de… | 1995 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152953 | Crit-Line Clip (Clic) Blood Chamber | 2015 | 6 |
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?
- Its one ancestor has a recall.
- Of its descendants, K152953 (Fresenius Medical Care North America, 2015) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KOC
2in 2025
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor‘s sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.
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/K141281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141281: Crit-Line Clip (Clic) Blood Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141281
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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