K212525 is an FDA 510(k) clearance for the Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Advcare Medical (New Taipei City, TW). The FDA issued a Cleared decision on August 19, 2022, 373 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 | K212525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2021 |
| Decision Date | August 19, 2022 |
| Days to Decision | 373 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 |