K253070 is an FDA 510(k) clearance for the Namic Radial Arm Band, 23 cm (DYNJRADBAND). This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on November 20, 2025, 58 days after receiving the submission on September 23, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K253070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2025 |
| Decision Date | November 20, 2025 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |