Cleared Traditional

K100446 - CIRCUFLOW 5100 SEQUENTIAL COMPRESSION D...

K100446 is the FDA 510(k) clearance for CIRCUFLOW 5100 SEQUENTIAL COMPRESSION D... by Devon Medical, Inc.. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K100446 · Devon Medical, Inc. · Cardiovascular device
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Mar 2010
Decision
16d
Days
Class 2
Risk

K100446 is an FDA 510(k) clearance for the CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Devon Medical, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Devon Medical, Inc. devices

Submission Details

510(k) Number K100446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2010
Decision Date March 05, 2010
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 114
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