FJK — Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Class II
FDA Device Classification
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 |
|---|
| 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 |
| K063290 | gambro renal products | GAMBRO QUICKSET BLOODLINES | January 30, 2007 |