Cleared Traditional

K040649 - KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE

K040649 is an FDA 510(k) clearance for KENDALL SCD EXPRESS KAMBIA THIGH LENGTH..., manufactured by Tyco Healthcare. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K040649 · Tyco Healthcare · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
126d
Days
Class 2
Risk

K040649 is an FDA 510(k) clearance for the KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on July 15, 2004 after a review of 126 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 devices

FDA 510(k) Submission Details - K040649

510(k) Number K040649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2004
Decision Date July 15, 2004
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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 248
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K040649.
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · Bio Compression Systems, Inc. · Feb 2005
FLOWMEDIC, MODEL 220
K042217 · Flowmedic (Israel), Ltd. · Jan 2005
C-BOOT
K041659 · C-Boot , Ltd. · Oct 2004
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