K251676 is an FDA 510(k) clearance for the Medline Microtek C-Flo Bag Decanter, Sterile (2000S). This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Microtek Medical, LLC (Northfiled, US). The FDA issued a Cleared decision on September 16, 2025, 109 days after receiving the submission on May 30, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K251676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | September 16, 2025 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |