K242320 is an FDA 510(k) clearance for the BD Vacutainer® One Use Holder. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on November 1, 2024, 88 days after receiving the submission on August 5, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K242320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2024 |
| Decision Date | November 01, 2024 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |