Cleared Special

K251446 - PlasmaFlow X Compression Sleeve Device (XPF0001) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K251446 is an FDA 510(k) clearance for the PlasmaFlow X Compression Sleeve Device (XPF0001). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Manamed, LLC (Denton, US). The FDA issued a Cleared decision on September 17, 2025 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Manamed, LLC devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K251446.
Compression Therapy Device (LGT-2202DVT)
K250242 · Guangzhou Longest Medical Technology Co., Ltd. · Apr 2026
NanoPress 760A-BT (760A-BT)
K254267 · Mego Afek , Ltd. · Feb 2026
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · Bio Compression Systems, Inc. · Dec 2025
Sequential Compression System (SCD600)
K250190 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
VenAir, Sequential Compression System (9P-089000)
K251466 · Wellell, Inc. · Oct 2025
PnueAira (PNCU-01)
K251086 · Biotab, LLC · Aug 2025