KDJ
- Product code
- KDJ
- Device name
- Set, Administration, For Peritoneal Dialysis, Disposable
- 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)
- 113 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250404 | 2025-04-03 | Fresenius Medical Care Renal Therapies… | staysafe® catheter extension set with Safe- Lock, 1… | |
| K231849 | 2024-03-12 | Baxter Healthcare | MiniCap Extended Life PD Transfer Set with Twist Cla… |
Official FDA classification page: KDJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).