5008x
5008X Venous Pressure Replacement Line with Transducer Protector
5manufacturers in China registered for this device type
7catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Fresenius Medical Care Renal Therapies Group, LLC, United States |
|---|---|
| FDA product code | FJK |
| Device type | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K243505 |
| Record published | 2025-08-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature. Protect from moisture, freezing and excessive heat. |
| Packaging | Pack of 24, pack of 200, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-5350-8 | In distribution | |
| 03-5300-3 | In distribution | |
| 03-5300-3C | In distribution | |
| 03-5160-1 | In distribution | |
| 03-5110-6 | In distribution | |
| 04-3000-9 | In distribution | |
| 04-9310-6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 58 |
| Nipro SET Blood Tubing SET With Transducer Protectors AND Priming SET | Nipro Medical Corporation | 12 |
| Hemodialysis Bloodlines | B. Braun Medical Inc. | 12 |
| CombiSet | Fresenius Medical Care | 11 |
| Cartridge Blood Set | Gambro Renal Products S.A. DE C.V. | 8 |
| Sunder | Sunder Biomedical Tech. Co., Ltd. | 6 |
| Streamline Airless System Set with Locksite Needleless Access Sites | Medisystems Corp. | 5 |
| Tablo(R) Cartridge | Outset Medical, Inc. | 5 |
| NovaLine | Bain Medical Equipment(Guangzhou) Co., Ltd. | 5 |
| Medisystems Hemodialysis Blood Tubing Sets | Medisystems Corp. | 4 |
| Diapact® | B. Braun Medical Inc. | 4 |
| Vital | Vital Healthcare SDN. BHD. | 3 |
Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213992 | 2023-05-31 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | UDI-DI | 2026-08-10 | Class II | Component change control | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | 120 units |
| Fresenius Medical Care Renal Therapies Group, LLC | UDI-DI | 2026-08-10 | Class II | Component change control | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | 62,544 units |
| Fresenius Medical Care Renal Therapies Group, LLC | UDI-DI | 2026-08-10 | Class II | Component change control | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | 18,600 |
| Fresenius Medical Care Renal Therapies Group, LLC | UDI-DI | 2026-08-10 | Class II | Component change control | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | 6,624 units |
| Fresenius Medical Care Renal Therapies Group, LLC | UDI-DI | 2026-05-11 | Class II | Process control | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. | 113,544 units (4,731 cases) |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-11-19 | Not classified | Device Design | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. | 190,080 units (7920 cases x 24 units) | 2012-11-03 |
| 2010-11-19 | Not classified | Device Design | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. | 10, 032 units (418 cases x 24 units) | 2012-11-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.