Cleared Special

PlasmaFlow X Compression Sleeve Device (XPF0001)

K251446 · Manamed, LLC · Cardiovascular
Sep 2025
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K251446 is an FDA 510(k) clearance for the PlasmaFlow X Compression Sleeve Device (XPF0001), 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 review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K251446 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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