FJK — Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Class II
FDA product code FJK covers "Set, Tubing, Blood, With And Without Anti-Regurgitation Valve", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FJK
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252423 | bain medical equipment (guangzhou) co | NovaLine Tubing Set for Hemodialysis (BL 124) | May 15, 2026 |
| K251341 | vital healthcare sdn. bhd | VITAL Tubing Sets for Hemodialysis | January 16, 2026 |
| K251442 | ningbo tianyi medical appliance co | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | October 2, 2025 |
| K243607 | diality | Moda-flx Hemodialysis System Cartridge (102121-001 ) | December 20, 2024 |
| K213992 | fresenius medical care renal therapies group | CombiSet Hemodialysis Blood Tubing Set | May 31, 2023 |
| K210782 | outset medical | Tablo Cartridge | November 26, 2021 |
| K202796 | jiangxi sanxin medtec co | SANSIN Tubing Sets for Hemodialysis | September 6, 2021 |
| K201866 | bain medical equipment (guangzhou) co | NovaLine Tubing Sets for Hemodialysis | March 10, 2021 |
| K171952 | dimesol | Dimesol Tubing Sets for Hemodialysis | March 30, 2018 |
| K161582 | bain medical equipment (guangzhou) co | DORA Tubing Sets for Hemodialysis | June 16, 2017 |
| K150304 | oxyless | Oxyless Blood Tubing Set | February 24, 2016 |
| K140841 | home dialysis plus | TABLO CARTRIDGE | September 11, 2014 |
| K112628 | nipro medical corporation | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | September 28, 2012 |
| K120823 | fresenius medical care north america, design cente | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTE | June 15, 2012 |
| K100364 | gambro renal products | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | November 3, 2010 |
| K090255 | nxstage medical | BLOOD TUBING SETS (STERILE FLUID PATH) | February 10, 2009 |
| K080807 | nxstage medical | BLOOD TUBING SETS (STERILE FLUID PATH) | July 18, 2008 |
| K070414 | gambro renal products | GAMBRO CARTRIDGE BLOOD SETS | October 12, 2007 |
| K072024 | nipro medical | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A21 | October 4, 2007 |
| K063293 | edwards lifesciences services | EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWAR | March 23, 2007 |