Blood Tubing Set
FDA 510(k) K884243 · Mediflex Intl.
510(k) numberK884243
Submission
- Device name
- Blood Tubing Set
- Applicant
- Mediflex Intl.
Fairfield, NJ, US - Received
- October 11, 1988
- Decision date
- December 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K915140 | Primary Dressing TrayLYY · Traditional | 02/11/1992SEKD |
| K900841 | Hemodialysis Transducer ProtectorFIB · Traditional | 05/15/1990SE |
| K891077 | Mediverse Parenteral Nutrition BagKPE · Traditional | 05/24/1989SE |
| K863496 | Mediflex Transducer ProtectorFIB · Traditional | 09/23/1986SE |
| K855039 | Mediflex Injection CapGCE · Traditional | 01/24/1986SE |
| K854346 | Mediflex Disposable Tubing ClampFPA · Traditional | 11/18/1985SE |
| K852106 | I.V. Administration SetFPA · Traditional | 06/07/1985SE |
| K843126 | Mediflex Drainage BagKNX · Traditional | 10/04/1984SE |
Questions and answers
When was Blood Tubing Set cleared by the FDA?
Blood Tubing Set (K884243) received a 510(k) decision of Substantially Equivalent on December 8, 1988, 58 days after the submission was received.
What is the product code of K884243?
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.