K212530 is an FDA 510(k) clearance for the IVX Fluid Transfer Set. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Omnicell, Inc. (Cranberry, US). The FDA issued a Cleared decision on April 24, 2022, 256 days after receiving the submission on August 11, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K212530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2021 |
| Decision Date | April 24, 2022 |
| Days to Decision | 256 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 |