510(k) · Cleared
ClearedVITAL Tubing Sets for Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Healthcare Sdn. Bhd. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Jan 16, 2026 as substantially equivalent to K201866 (Bain Medical Equipment (Guangzhou) Co., Ltd., 2021) after a 261-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jan 16, 2026
- Review
- 261 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010264 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
- 3 generations backK072024 Nipro Blood Tubing Set with Transducer Protector and Priming Set…Nipro Medical Corp. · 2007 · Recalled
- 2 generations backK161582 DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2017
- 1 generation backK201866 NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2021
- This deviceK251341 VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming… | Nipro Medical Corp. | 2001 | — |
| −3 | K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model… | Nipro Medical Corp. | 2007 | 1 |
| −2 | K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017 | — |
| −1 | K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021 | — |
| 0 (this device) | K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | 2026 | — |
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.
Planning a device in FJK? 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 |
|---|---|---|---|
| * | K201866 | NovaLine Tubing Sets for HemodialysisSummary page 7…Page 3 of 8 to achieve a Sterility Assurance Level (SAL) of 10 -6. 5. Identification of Predicate Device 510(k) Number: K201866 Product Name: NovaLine Tubing Sets for Hemodialysis Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd 6. Non-Clinical… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K201866.
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. 2026, 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 VITAL Tubing Sets for Hemodialysis are sterile, single-use arterial and venous blood lines for exclusive use with AK98 (model BLU014E, BLU015E, BLU021E, BLU022E, BLU025E), Fresenius 2008 series (model BLU001E, BLU002E, BLU003E, BLU004E, BLU005E, BLU006E, BLU007E, BLU008E, BLU009E, BLU010E, BLU011E, BLU012E, BLU013E, BLU016E, BLU017E, BLU018E, BLU020E, BLU023E, BLU024E, BLU029E, BLU030E, BLU063E), Fresenius 5008X (model BLU026E, BLU027E) or Bbraun…
Read the full statement (117 words)
The VITAL Tubing Sets for Hemodialysis are sterile, single-use arterial and venous blood lines for exclusive use with AK98 (model BLU014E, BLU015E, BLU021E, BLU022E, BLU025E), Fresenius 2008 series (model BLU001E, BLU002E, BLU003E, BLU004E, BLU005E, BLU006E, BLU007E, BLU008E, BLU009E, BLU010E, BLU011E, BLU012E, BLU013E, BLU016E, BLU017E, BLU018E, BLU020E, BLU023E, BLU024E, BLU029E, BLU030E, BLU063E), Fresenius 5008X (model BLU026E, BLU027E) or Bbraun Dialog series Hemodialysis system (model BLU019E, BLU028E). The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.
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/K251341 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251341: VITAL Tubing Sets for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251341
Report an extraction error
Are you the manufacturer?
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