510(k) · Cleared
ClearedCombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
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 Sep 18, 2020 as substantially equivalent to K172238 (Fresenius Medical Care Renal Therapies Group, LLC, 2017) and 1 other predicate after a 136-day review. Its family tree reaches back 4 generations to 1996. 1 of the 14 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Sep 18, 2020
- Review
- 136 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953823 (1996). 8 ancestors in all, the oldest K935958 (1995). 5 later devices descend from it, 3 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK953823 Arterial Venous Blood Tubing SetMedisystems Corp. · 1996
- 3 generations backK994306 ReversoMedisystems Corp. · 2000
- 2 generations backK022536 \Resenius Access Flow Reserving Connectors, Fresenius Standalone…Fresenius Medical Care · 2002 · Recalled
- 1 generation backK172238 CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC · 2017
- This deviceK201207 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 · cites it directly · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · cites it directly · 1 of its ownK213992 CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK251851 DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK251442 TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd. · 2025
Class I recalls in this family
- K080807 Blood Tubing Sets (Sterile Fluid Path)2 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · cites it directly2descendants
- K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · cites it directly1descendant
- K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · cites it directly1descendant
- K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on0descendants
- K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953823 | Arterial Venous Blood Tubing Set | Medisystems Corp. | 1996 | — |
| −3 | K994306 | Reverso | Medisystems Corp. | 2000 | — |
| −2 | K022536 | \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow… | Fresenius Medical Care | 2002 | 3 |
| −1 | K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017 | — |
| 0 (this device) | 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 |
| +1 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| +1 | K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 1 |
| +2 | K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
| +2 | K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2008 | 1 | 1 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K172238 | CAREline Airless Hemodialysis Blood Tubing SetsSummary page 4…erology/Urology 5.3. Legally Marketed Predicate Device The legally marketed primary predicate device is the CAREline Hemodialysis Blood Tubing Sets cleared under K172238. The legally marketed secondary predicate device is the Crit-Line Clip (CLiC) Blood Chamber cleared under K152953. These devices… | 2017 |
| * | K152953 | Crit-Line Clip (Clic) Blood ChamberSummary page 4…e CAREline Hemodialysis Blood Tubing Sets cleared under K172238. The legally marketed secondary predicate device is the Crit-Line Clip (CLiC) Blood Chamber cleared under K152953. These devices have not been subject to a design- related recall. The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set wi… | 2015 |
| † | K120823 | BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors | 2012 |
What descends from it? (5)
3 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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231534 (Fresenius Medical Care, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K172238.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Blood Tubing Set is a sterile, single use, disposable 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 Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines equipped with Crit-Line hardware.
The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor’s sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201207: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201207
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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