K192154 is an FDA 510(k) clearance for the Rio Vial-to-Bag Drug Reconstitution Device. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Icu Medical (San Clemente, US). The FDA issued a Cleared decision on April 20, 2020, 255 days after receiving the submission on August 9, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K192154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2019 |
| Decision Date | April 20, 2020 |
| Days to Decision | 255 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 |