Cleared Traditional

UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF (K241746) - FDA 510(k) Clearance

Also marketed or referenced as:
UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050 UMED REPROCESSED CTC VP 501 CALF CUFF UMED REPROCESSED CTC VP 520 FOOT CUFF

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241746 · United Medical Resources, LLC · Cardiovascular device
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Oct 2024
Decision
108d
Days
Class 2
Risk

K241746 is an FDA 510(k) clearance for the UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by United Medical Resources, LLC (North Salt Lake, US). The FDA issued a Cleared decision on October 4, 2024 after a review of 108 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all United Medical Resources, LLC devices

Submission Details

510(k) Number K241746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2024
Decision Date October 04, 2024
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 91
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K241746.
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