Cleared Traditional

K021654 - REPROCESSED COMPRESSION SLEEVE

K021654 is an FDA 510(k) clearance for REPROCESSED COMPRESSION SLEEVE, manufactured by Alliance Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K021654 · Alliance Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
261d
Days
Class 2
Risk

K021654 is an FDA 510(k) clearance for the REPROCESSED COMPRESSION SLEEVE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Alliance Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on February 5, 2003 after a review of 261 days - an extended review 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: 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.

FDA 510(k) Submission Details - K021654

510(k) Number K021654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date February 05, 2003
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
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 345
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K021654.
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp. · Mar 2003
TRAVELAIR PORTABLE COMPRESSION SYSTEM
K022340 · Dynamic Air, Inc. · Feb 2003
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
K023800 · Aircast, Inc. · Feb 2003
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
K021509 · Hygia Health Services, Inc. · Dec 2002
WIZAIR COMPRESSION SYSTEM
K023573 · Medical Compression Systems (Dbn) , Ltd. · Nov 2002
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K022753 · Medical Device Services · Nov 2002
K021654 · REPROCESSED COMPRESSION SLEEVE
Download PDF FDA Summary Alliance Medical, Inc.