510(k) · Cleared
ClearedNovaLine Tubing Set for Hemodialysis (BL 124)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bain Medical Equipment (Guangzhou) Co., Ltd. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on May 15, 2026 as substantially equivalent to K201866 (Bain Medical Equipment (Guangzhou) Co., Ltd., 2021) after a 287-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 15, 2026
- Review
- 287 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 deviceK252423 NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd. · 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) | K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 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 K251442 TIANYI Extracorporeal Blood Tubing Set…score 11.6 · 6 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 6…r, the bloodline set and any other accessories combined) shall not exceed 10% of the patient's blood volume. 5. Identification of Predicate Device 510(k) Number: K201866 Product Name: NovaLine Tubing Sets for Hemodialysis - Models BL11 and BL12 Manufacturer: Bain Medical Equipment (Guangzhou) Co.,… | 2021 |
| † | K213015 | DORA Disposable A.V. Fistula Needle Sets | 2022 |
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 2 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 NovaLine Tubing Set for Hemodialysis - BL 124 - is sterile, single-use arterial and venous blood line for exclusive use with the Vantive AK 98 delivery System. The bloodline serves 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/K252423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252423: NovaLine Tubing Set for Hemodialysis (BL 124).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252423
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026