K213992 is an FDA 510(k) clearance for the CombiSet Hemodialysis Blood Tubing Set. This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 31, 2023, 526 days after receiving the submission on December 21, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K213992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2021 |
| Decision Date | May 31, 2023 |
| Days to Decision | 526 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |