DORA Tubing Sets for Hemodialysis
FDA 510(k) K161582 · Bain Medical Equipment (Guangzhou) Co., Ltd.
510(k) numberK161582
Submission
- Device name
- DORA Tubing Sets for Hemodialysis
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd.
Guangzhou, CN - Received
- June 8, 2016
- Decision date
- June 16, 2017
- 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 |
| K150304 | Oxyless Blood Tubing SetFJK · Abbreviated | Oxyless, Ltd. | 02/24/2016SE |
More from Oxyless, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | 05/15/2026SE |
| K240164 | NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional | 06/28/2024SE |
| K213015 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | 04/08/2022SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | 03/10/2021SE |
| K203524 | Surgical MasksFXX · Traditional | 02/25/2021SE |
| K163025 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | 07/20/2017SE |
Questions and answers
When was DORA Tubing Sets for Hemodialysis cleared by the FDA?
DORA Tubing Sets for Hemodialysis (K161582) received a 510(k) decision of Substantially Equivalent on June 16, 2017, 373 days after the submission was received.
What is the product code of K161582?
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.