K251446 is an FDA 510(k) clearance for the PlasmaFlow X Compression Sleeve Device (XPF0001). This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Manamed, LLC (Denton, US). The FDA issued a Cleared decision on September 17, 2025, 131 days after receiving the submission on May 9, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K251446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2025 |
| Decision Date | September 17, 2025 |
| Days to Decision | 131 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |