K223198 is an FDA 510(k) clearance for the BD Intraosseous Vascular Access System EMS Powered Driver (D001003). This device is classified as a Needle, Interosseous (Class II - Special Controls, product code MHC).
Submitted by Bard Access Systems (Salt Lake Ciy,, US). The FDA issued a Cleared decision on November 10, 2022, 28 days after receiving the submission on October 13, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K223198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2022 |
| Decision Date | November 10, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MHC - Needle, Interosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |