FKX
- Product code
- FKX
- Device name
- System, Peritoneal, Automatic Delivery
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5630
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 83 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250523 | 2025-10-02 | Simergent, LLC | Archimedes Pro Automated Peritoneal Dialysis Cycler … | |
| K243371 | 2025-05-16 | Byonyks Pvt, Ltd. | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-… |
Official FDA classification page: FKX
Classification and pathway per current FDA publications. Data from openFDA (CC0).