510(k) · Cleared
ClearedCAREline Airless Hemodialysis Blood Tubing Sets
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 Dec 14, 2017 as substantially equivalent to K022536 (Fresenius Medical Care, 2002) and 1 other predicate after a 141-day review. Its family tree reaches back 3 generations to 1996. 1 of the 11 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Dec 14, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953823 (1996). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK953823 Arterial Venous Blood Tubing SetMedisystems Corp. · 1996
- 2 generations backK994306 ReversoMedisystems Corp. · 2000
- 1 generation backK022536 \Resenius Access Flow Reserving Connectors, Fresenius Standalone…Fresenius Medical Care · 2002 · Recalled
- This deviceK172238 CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC · 2017
- Descendant · cites it directly · 5 of its ownK201207 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached…Fresenius Medical Care Renal Therapies Group, LLC · 2020
- Descendant · cites it directly · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK213992 CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080807 Blood Tubing Sets (Sterile Fluid Path)direct predicate · 2008
Most influential descendants
Showing 5 of 6 · See all- K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Fresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly5descendants
- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · cites it directly2descendants
- K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on1descendant
- K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · 2 generations on1descendant
- K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953823 | Arterial Venous Blood Tubing Set | Medisystems Corp. | 1996 | — |
| −2 | K994306 | Reverso | Medisystems Corp. | 2000 | — |
| −1 | K022536 | \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow… | Fresenius Medical Care | 2002 | 3 |
| 0 (this device) | K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017 | — |
| +1 | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and… | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
| +1 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
| +2 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| +2 | K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 1 |
| +3 | K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 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? (2)
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 |
|---|---|---|---|
| * | K022536 | \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving…Summary page 4…mary Predicate - CombiSet® Blood Tubing with Access Flow Reversing Connector (Twister®) CombiSet Blood Tubing with Access Flow Reversing Connector (Twister), K022536, is the primary predicate for the CAREline Airless Hemodialysis Blood Tubing Sets (hereafter referred to as “CAREline bloodlines”… | 2002 |
| * | K080807 | Blood Tubing Sets (Sterile Fluid Path)Summary page 4…Secondary Predicate - Streamline Airless System Set with Locksite® Needleless Access Site Streamline Airless System Set with Locksite Needleless Access Site, K080807, is the secondary predicate for the CAREline bloodlines.… | 2008 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K080807Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201207 (Fresenius Medical Care Renal Therapies Group, LLC, 2020) has gone furthest, with 5 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. 2017, 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?
CAREline Twister The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during…
Read the full statement (177 words)
CAREline Twister
The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.
Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.
CAREline Standard
The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172238: CAREline Airless Hemodialysis Blood Tubing Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172238
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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