510(k) · Cleared
ClearedTIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Tianyi Medical Appliance Co., Ltd. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Oct 2, 2025 as substantially equivalent to K213992 (Fresenius Medical Care Renal Therapies Group, LLC, 2023) after a 146-day review. Its family tree reaches back 6 generations to 1996. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 2, 2025
- Review
- 146 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953823 (1996). 10 ancestors in all, the oldest K935958 (1995). No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK953823 Arterial Venous Blood Tubing SetMedisystems Corp. · 1996
- 5 generations backK994306 ReversoMedisystems Corp. · 2000
- 4 generations backK022536 \Resenius Access Flow Reserving Connectors, Fresenius Standalone…Fresenius Medical Care · 2002 · Recalled
- 3 generations backK172238 CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC · 2017
- 2 generations backK201207 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached…Fresenius Medical Care Renal Therapies Group, LLC · 2020
- 1 generation backK213992 CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
- This deviceK251442 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)4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953823 | Arterial Venous Blood Tubing Set | Medisystems Corp. | 1996 | — |
| −5 | K994306 | Reverso | Medisystems Corp. | 2000 | — |
| −4 | K022536 | \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow… | Fresenius Medical Care | 2002 | 3 |
| −3 | K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017 | — |
| −2 | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and… | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
| −1 | K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K213992 | CombiSet Hemodialysis Blood Tubing SetSummary page 5…Product Code: FJK Regulation Number: 876.5820 Review Panel: Gastroenterology/Urology 4. PREDICATE DEVICE Device Name: CombiSet Hemodialysis Blood Tubing Set K213992 Regulation number: 21 CFR 876.5820 Regulation Class: Class II Product Code: FJK… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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?
TIANYI Extracorporeal Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer.
TIANYI Extracorporeal Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
TIANYI Extracorporeal 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/K251442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251442: TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251442
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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