Cleared Traditional

K040511 - SCD EXPRESS PORTABLE COMPRESSION SYSTEM

K040511 is an FDA 510(k) clearance for SCD EXPRESS PORTABLE COMPRESSION SYSTEM, manufactured by Tyco Healthcare/Kendall. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K040511 · Tyco Healthcare/Kendall · Cardiovascular device
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Jun 2004
Decision
122d
Days
Class 2
Risk

K040511 is an FDA 510(k) clearance for the SCD EXPRESS PORTABLE COMPRESSION SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Tyco Healthcare/Kendall (Mansfield, US). The FDA issued a Cleared decision on June 28, 2004 after a review of 122 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 Tyco Healthcare/Kendall devices

FDA 510(k) Submission Details - K040511

510(k) Number K040511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2004
Decision Date June 28, 2004
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

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 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K040511.
REPROCESSED COMPRESSION SLEEVES
K060049 · Alliance Medical Corp. · Feb 2006
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
K060091 · Alliance Medical Corp. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K053316 · Alliance Medical Corp. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K024087 · Alliance Medical Corp. · Mar 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp. · Mar 2003
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc. · Feb 2002