KOC
- Product code
- KOC
- Device name
- Accessories, Blood Circuit, Hemodialysis
- 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)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 182 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242479 | 2025-05-15 | NIKKISO CO., LTD. | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archl… | |
| K242176 | 2025-05-15 | NIKKISO CO., LTD. | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archl… |
Official FDA classification page: KOC
Classification and pathway per current FDA publications. Data from openFDA (CC0).