K251980 is an FDA 510(k) clearance for the ClaveQS™ Bag. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on March 20, 2026, 266 days after receiving the submission on June 27, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K251980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2025 |
| Decision Date | March 20, 2026 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |