K242176 is an FDA 510(k) clearance for the BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U). This device is classified as a Accessories, Blood Circuit, Hemodialysis (Class II - Special Controls, product code KOC).
Submitted by NIKKISO CO., LTD. (Shibuya-Ku, JP). The FDA issued a Cleared decision on May 15, 2025, 295 days after receiving the submission on July 24, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K242176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2024 |
| Decision Date | May 15, 2025 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOC - Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |