K190305 is an FDA 510(k) clearance for the Additive Cap. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on April 30, 2019, 77 days after receiving the submission on February 12, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K190305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2019 |
| Decision Date | April 30, 2019 |
| Days to Decision | 77 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 |