FJK
- Product code
- FJK
- Device name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 77 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252423 | 2026-05-15 | Bain Medical Equipment (Guangzhou) Co.… | NovaLine Tubing Set for Hemodialysis (BL 124) | |
| K251341 | 2026-01-16 | Vital Healthcare Sdn. Bhd. | VITAL Tubing Sets for Hemodialysis | |
| K251442 | 2025-10-02 | Ningbo Tianyi Medical Appliance Co., L… | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | |
| K243607 | 2024-12-20 | Diality, Inc. | Moda-flx Hemodialysis System Cartridge (102121-001 … |
Official FDA classification page: FJK
Classification and pathway per current FDA publications. Data from openFDA (CC0).