Hemodialysis Blood Tubing Set
FDA 510(k) K920797 · National Medical Care, Medical Products Div., Inc.
510(k) numberK920797
Submission
- Device name
- Hemodialysis Blood Tubing Set
- Applicant
- National Medical Care, Medical Products Div., Inc.
Rockleigh, NJ, US - Received
- February 21, 1992
- Decision date
- September 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K962081 | Combilines Hemodialysis Blood Tubing SetFJK · Traditional | 11/01/1996SE |
| K941757 | Formalin Reuse CartLIF · Traditional | 01/22/1996SE |
| K952343 | Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber DialyzerFJI · Traditional | 12/22/1995SE |
| K930843 | Rapid Disconnect Y-Set, Cat. No. 48-7000KDJ · Traditional | 08/31/1994SE |
| K914790 | Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-RFJI · Traditional | 03/05/1993SE |
| K920697 | Dextrolyte II Peritoneal Dialysis 48-3029-7 ClampFJH · Traditional | 09/21/1992SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | 09/21/1992SE |
| K920586 | Dextrolyte II Peritoneal Dialysis Admin. SetKDJ · Traditional | 09/21/1992SE |
| K920029 | Dextrolyte II Capd Trnsfer SetKDJ · Traditional | 09/21/1992SE |
| K915628 | Dextrolyte II Peritoneal Dialysis PumpKDJ · Traditional | 03/16/1992SE |
Questions and answers
When was Hemodialysis Blood Tubing Set cleared by the FDA?
Hemodialysis Blood Tubing Set (K920797) received a 510(k) decision of Substantially Equivalent on September 21, 1992, 213 days after the submission was received.
What is the product code of K920797?
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.