510(k) · Cleared
Recalled · Class II · 2026CombiSet Hemodialysis Blood Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on May 31, 2023 as substantially equivalent to K201207 (Fresenius Medical Care Renal Therapies Group, LLC, 2020) after a 526-day review. Its family tree reaches back 5 generations to 1996. 1 of the 11 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- May 31, 2023
- Review
- 526 days
- Class
- Class II
- Product code
- FJK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953823 (1996). 9 ancestors in all, the oldest K935958 (1995). 1 later device descends from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK953823 Arterial Venous Blood Tubing SetMedisystems Corp. · 1996
- 4 generations backK994306 ReversoMedisystems Corp. · 2000
- 3 generations backK022536 \Resenius Access Flow Reserving Connectors, Fresenius Standalone…Fresenius Medical Care · 2002 · Recalled
- 2 generations backK172238 CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC · 2017
- 1 generation backK201207 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached…Fresenius Medical Care Renal Therapies Group, LLC · 2020
- This deviceK213992 CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023
- Descendant · cites it directly · 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)3 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953823 | Arterial Venous Blood Tubing Set | Medisystems Corp. | 1996 | — |
| −4 | K994306 | Reverso | Medisystems Corp. | 2000 | — |
| −3 | K022536 | \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow… | Fresenius Medical Care | 2002 | 3 |
| −2 | 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 | — |
| 0 (this device) | K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | — |
| +1 | 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 |
|---|---|---|
| 2025 | 1 | 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 FJK device
- #1 K252423 NovaLine Tubing Set for Hemodialysis (BL 124)score 12.2 · 4 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 |
|---|---|---|---|
| * | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Summary page 4…icate Device The legally marketed predicate device is the CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as “CombiSet SMARTECH”) cleared under K201207. The predicate device has not been subject to a design-related recall. 5.4. Device Description 5.4.1. Device Identif… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2026 | Class II | Z-3225-2026 | Use error | Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. |
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251442 (Ningbo Tianyi Medical Appliance Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K201207.
How does its category compare?
All FJK devicesFJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FJK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FJK
255in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FJK
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FJK
1,487in 2025
MAUDE reports naming product code FJK, 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 | 4 | 116 | 2 | 135 |
| 2008 | 1 | — | 2 | 86 |
| 2009 | 1 | — | 0 | 76 |
| 2010 | 1 | — | 2 | 130 |
| 2011 | 0 | — | 0 | 243 |
| 2012 | 2 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 114 |
| 2014 | 1 | — | 0 | 116 |
| 2015 | 0 | — | 1 | 126 |
| 2016 | 1 | — | 0 | 139 |
| 2017 | 1 | — | 0 | 131 |
| 2018 | 1 | — | 0 | 119 |
| 2019 | 0 | — | 0 | 185 |
| 2020 | 0 | — | 1 | 190 |
| 2021 | 3 | 255 | 0 | 188 |
| 2022 | 0 | — | 0 | 362 |
| 2023 | 1 | — | 0 | 585 |
| 2024 | 1 | — | 0 | 417 |
| 2025 | 1 | — | 1 (1) | 1,487 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
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.
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/K213992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213992: CombiSet Hemodialysis Blood Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213992
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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