K251275 is an FDA 510(k) clearance for the VitalStream ART Connect. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Caretaker Medical (Charlottesville, US). The FDA issued a Cleared decision on September 26, 2025, 155 days after receiving the submission on April 24, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K251275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2025 |
| Decision Date | September 26, 2025 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXG - Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |