K252423 · Bain Medical Equipment (Guangzhou) Co., Ltd. · FJK · May 15, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K252423
Device Name
NovaLine Tubing Set for Hemodialysis (BL 124)
Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd.
Product Code
FJK · Gastroenterology, Urology
Decision Date
May 15, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
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.
Device Story
Extracorporeal blood circuit for hemodialysis; consists of arterial and venous tubing sets; interfaces with Vantive AK 98 delivery system pump rotor to drive blood flow. Used in clinical settings by healthcare providers; physician selects appropriate dialyzer and tubing set based on patient blood volume (total extracorporeal volume must not exceed 10% of patient blood volume). Provides sterile, single-use pathway for blood purification; ensures safe transport of blood through hemodialyzer. Benefits patient by facilitating necessary hemodialysis treatment.
Clinical Evidence
No clinical data. Bench testing only, including performance testing, side-by-side testing, mechanical hemolysis testing, and hemodialysis machine compatibility testing. Compliance with ISO 8637-2:2024 and ISO 80369-7:2021 verified.
Indicated for patients undergoing hemodialysis treatment requiring an extracorporeal blood circuit to transport blood from the patient through a hemodialyzer and back to the patient.
Regulatory Classification
Identification
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Predicate Devices
NovaLine Tubing Sets for Hemodialysis - Models BL11 and BL12 (K201866)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 15, 2026
Bain Medical Equipment(Guangzhou) Co., Ltd.
Zoe Zeng
Regulatory Affair Supervisor
No.10, Juncheng Road, Eastern Area,
Economic and Technological Development
Guangzhou, 510760
China
Re: K252423
Trade/Device Name: NovaLine Tubing Set for Hemodialysis (BL 124)
Regulation Number: 21 CFR 876.5820
Regulation Name: Hemodialysis System And Accessories
Regulatory Class: Class II
Product Code: FJK
Dated: April 15, 2026
Received: April 15, 2026
Dear Zoe Zeng:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252423 - Zoe Zeng
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K252423 - Zoe Zeng
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# MAURA ROONEY -S
Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252423 | ? |
| Please provide the device trade name(s). | | ? |
| NovaLine Tubing Set for Hemodialysis (BL 124) | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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K252423
510(k) Summary
page 1 of 5
# 024_Update 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K252423
1. Date of Preparation: April 10, 2026
2. Sponsor Identification
**Bain Medical Equipment (Guangzhou) Co., Ltd.**
No.10, Juncheng Road, Eastern Area, Economic and Technological Development, 510760, Guangdong, P.R.China
Establishment Registration Number: 3013217742
Contact Person: Sophia Shao
Position: Management Representative
Tel: +86-20-66856868 ext.218
Fax: +86 20 3206 7500
Email: sophia@baingz.com
3. Designated Submission Correspondent
**Bain Medical Equipment (Guangzhou) Co., Ltd.**
No.10, Juncheng Road, Eastern Area, Economic and Technological Development, 510760, Guangdong, P.R.China
Ms. Zoe Zeng (Primary Contact Person)
Tel: +86-20-66856868 ext.290
Fax: +86 20 3206 7500
Email: zoe@baingz.com
Ms. Sophia Shao (Alternative Contact Person)
Tel: +86-20-66856868 ext.218
Fax: +86 20 3206 7500
Email: sophia@baingz.com
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K252423
510(k) Summary
page 2 of 5
## 4. Identification of Proposed Device
Trade Name: NovaLine Tubing Set for Hemodialysis
Common Name: Hemodialysis Tubing Set
Models: BL 124
### Regulatory Information
Classification Name: Set, Tubing, Blood, With and Without Anti-Regurgitation Valve
Classification: II
Product Code: FJK
Regulation Number: CFR876.5820
Review Panel: Gastroenterology/Urology
### Indications for use:
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.
### Device Description
The NovaLine Tubing Sets for Hemodialysis consists of an Arterial line and a Venous line. The tubing is soft, transparent, smooth and non-kink to ensure the good liquidity.
The proposed devices are provided in sterile condition, it is subject to e-beam sterilization prior to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
The choice of the proper dialyzer and blood line set is the responsibility of the physician in charge. When selecting bloodline set for a treatment, the total extracorporeal blood volume (i.e. the dialyzer, 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., Ltd
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K252423
510(k) Summary
page 3 of 5
## 6. Non-Clinical Test Conclusion
Non clinical tests, such as performance testing, side by side testing, mechanical hemolysis testing and hemodialysis machine compatibility testing were conducted to verify that the proposed device meet all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 8637-2:2024 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialyzer, haemodiafilters, haemofilter and haemoconcentrators.
- ISO 80369-7:2021 Small bore connectors for liquids and gases in healthcare applications- Part 7: Connectors for intravascular or hypodermic applications
## 7. Clinical Test Conclusion
No clinical study is included in this submission.
## 8. Substantially Equivalent (SE) Comparison
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
| Technological Characteristic | Proposed Device K252423 | Predicate Device K201866 | Remark |
| --- | --- | --- | --- |
| Device Class | II | II | SE |
| Product Code | FJK | FJK | SE |
| Regulation Number | 21CFR part 876.5820 | 21CFR part 876.5820 | SE |
| Indications for Use | The NovaLine Tubing Set for Hemodialysis – BL 124 – is sterile, single-use arterial and venous blood lines 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. | The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. 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. | SE |
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K252423
510(k) Summary
page 4 of 5
| Technological Characteristic | | Proposed Device K252423 | Predicate Device K201866 | Remark |
| --- | --- | --- | --- | --- |
| | | the circuit. | | |
| Feature | | Pre-Pump Post-Pump Color Coded component Sterile Non-pyrogenic Single Use Prescription Device | Pre-Pump Post-Pump Color Coded component Sterile Non-pyrogenic Single Use Prescription Device | SE |
| Main Configuration | Drip Chamber | Drip Chamber | Discussion 1 | |
| | | Main Tubing | | Main Tubing |
| | | Branch Tubing | | Branch Tubing |
| | | Female Luer Lock | | Female Luer Lock |
| | | Clamps | | Clamps |
| | | Filters | | Filters |
| | | Venous Line | | Venous Line |
| | | Main Tubing | | Main Tubing |
| | | Branch Tubing | | Branch Tubing |
| | | Female Luer Lock | | Female Luer Lock |
| | | Clamps | | Clamps |
| | | Filters | | Filters |
| Physical performance | Priming Volume (mL/mm) | BL 124: 88±10% ml | BL 12: 186±10% ml | Discussion 2 |
| | Positive pressure Limitation (mmHg) | 500 | 500 | |
| | Negative Pressure Limitation (mmHg) | -500 | -500 | |
| Performance | | Conforms to ISO 8637-2:2024 ISO 80369-7:2021 | Conforms to ISO8638:2010 ISO594-2:1998 | Discussion 3 |
| Materials | | The major components of the NovaLine Tubing Sets for Hemodialysis are made from medical-grade PVC, PP, PC, ABS, PE and other medical-grade macromolecule | The major components of the NovaLine Tubing Sets for Hemodialysis are made from medical-grade PVC, PP, PC, ABS, PE and other medical-grade macromolecule materials. | Discussion 4 |
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K252423
510(k) Summary
page 5 of 5
| Technological Characteristic | Proposed Device K252423 | Predicate Device K201866 | Remark |
| --- | --- | --- | --- |
| | materials. | | |
| **Biocompatibility** | Conforms to ISO 10993 series standards | Conforms to ISO 10993 series standards | SE |
| **Sterilization** | EBEAM, SAL(10-6) | EBEAM, SAL(10-6) | SE |
| **Labeling** | Direction for Use | Direction for Use | SE |
| | Intended Use | Intended Use | |
| | Description | Description | |
| | Warnings and Cautions | Warnings and Cautions | |
## Discussion 1 - Main Configuration & Discussion 2 - Physical Performance
The proposed device has the similar design of the components with the predicated device. The priming volume of the proposed and predicate device is different due to their length of main tubes is different. Differences in the structure, tubing length and priming volume can impact the mechanical and performance characteristics of device. The side by side bench tests such as pressure leak test, endurance testing, priming volume test, tensile strength test, mechanical hemolysis test, tube kinking inspection, blood pump segment validation were conducted to prove that the proposed device meet the requirements of mechanical and performance characteristics. Therefore, the differences in configuration and priming volume will not lead to new safety and effectiveness problems.
## Discussion 3 - Performance
The ISO standard of the predicate device, ISO8638-2010 has been withdrawn and replaced with ISO8637-2, whereas ISO594-2 has also been replaced with ISO80369-7. Updated ISO version will not lead to new safety and effectiveness issue in the proposed device.
## Discussion 4 - Materials
The proposed device and the predicate device (K201866) utilize the same categories of medical-grade materials (e.g., PVC, PP, PC, ABS, PE) for blood-contacting components. Although the specific raw material model for the main tubing differs, this model has a history of use in the pump segment of the predicate device itself, under identical blood contact conditions. Additionally, the difference in colorant for small clamps is supported by the use of the same material with white colorant in an equivalent component of another legally marketed device (K213015). These differences will not lead to new safety and effectiveness problems.
Based on the comparison and analysis in Substantially Equivalent Discussion, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
