BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
FDA 510(k) K120823 · Fresenius Medical Care North America, Design Cente
510(k) numberK120823
Submission
- Device name
- BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
- Applicant
- Fresenius Medical Care North America, Design Cente
Waltham, MA, US - Received
- March 19, 2012
- Decision date
- June 15, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 05/15/2026SE |
| K251341 | VITAL Tubing Sets for HemodialysisFJK · Traditional | Vital Healthcare Sdn. Bhd. | 01/16/2026SE |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)FJK · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 10/02/2025SE |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 )FJK · Special | Diality, Inc. | 12/20/2024SE |
| K213992 | CombiSet Hemodialysis Blood Tubing SetFJK · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/31/2023SE |
| K210782 | Tablo CartridgeFJK · Traditional | Outset Medical, Inc. | 11/26/2021SE |
| K202796 | SANSIN Tubing Sets for HemodialysisFJK · Traditional | Jiangxi Sanxin Medtec Co., Ltd. | 09/06/2021SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 03/10/2021SE |
| K171952 | Dimesol Tubing Sets for HemodialysisFJK · Traditional | Dimesol, Inc. | 03/30/2018SE |
| K161582 | DORA Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/16/2017SE |
More from Bain Medical Equipment (Guangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K123630 | Fresenius Liberty CyclerFKX · Traditional | 09/09/2013SE |
| K121421 | Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)ONW · Special | 01/17/2013SE |
| K120505 | Fresenius 2008T Hemodialysis MachineKDI · Special | 03/06/2012SE |
| K101715 | Fresenius 2008T Hemodialysis Machine Model 190573KDI · Traditional | 12/21/2010SE |
Questions and answers
When was BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors cleared by the FDA?
BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (K120823) received a 510(k) decision of Substantially Equivalent on June 15, 2012, 88 days after the submission was received.
What is the product code of K120823?
The FDA product code is FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, a Class II (moderate risk) device regulated under 21 CFR 876.5820.