510(k) · Cleared
Recalled · Class II · 2016Crit-Line Clip (Clic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care-North America · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Nov 9, 2012 as substantially equivalent to K972470 (In-Line Diagnostics Corp., 1997) after a 161-day review. Its family tree reaches back 1 generation to 1997. 3 of the 14 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled once.
- Decided
- Nov 9, 2012
- Review
- 161 days
- Class
- Class II
- Product code
- KOC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972470 (1997). 12 later devices descend from it, 2 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK972470 Crit-Line Monitor (Clmiii)In-Line Diagnostics Corp. · 1997
- This deviceK121599 Crit-Line Clip (Clic)Fresenius Medical Care-North America · 2012
- Descendant · cites it directly · 10 of its ownK131908 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013
- Descendant · 2 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 · 3 generations on · 8 of its ownK153449 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · Recalled
- Descendant · 4 generations on · 7 of its ownK173972 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- Descendant · 5 generations on · 4 of its ownK231125 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC · 2013 · cites it directly10descendants
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2015 · 2 generations on9descendants
- K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016 · 3 generations on8descendants
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 4 generations on7descendants
- K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2023 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972470 | Crit-Line Monitor (Clmiii) | In-Line Diagnostics Corp. | 1997 | — |
| 0 (this device) | K121599 | Crit-Line Clip (Clic) | Fresenius Medical Care-North America | 2012 | — |
| +1 | K131908 | 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) | Fresenius Medical Care Renal Therapies Group, LLC | 2013 | — |
| +2 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T… | Fresenius Medical Care Renal Therapies Group, LLC | 2015 | Class I |
| +3 | K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016 | 2 |
| +4 | K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
| +5 | K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 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 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 |
|---|---|---|---|
| * | K972470 | Crit-Line Monitor (Clmiii)Summary page 1…5820 Product Code /Classification Panel: 78 MQS/Gastroenterology/Urology Panel C. Legally Marketed Predicate Device (unmodified device) Crit-Line III Monitor (K972470). Page 77 of 209… | 1997 |
What descends from it? (12)
See all 122 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2016 | Class II | Z-2044-2016 | Software design | Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop. |
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 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 18 Class I recalls
- K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 18 Class I recalls
- K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 monitor (CLIC) is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. CLiC measures 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. Based on the data that the monitor provides, the…
Read the full statement (116 words)
The Crit-Line Clip monitor (CLIC) is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. CLiC measures 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. Based on the data that the monitor provides, the clinician/nurse, under physician direction, 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 as stated in the FDA summary.
https://510kreport.com/device/K121599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121599: Crit-Line Clip (Clic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121599
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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