Cleared Special

K002287 - WIZAIR COMPRESSION SYSTEM

K002287 is an FDA 510(k) clearance for WIZAIR COMPRESSION SYSTEM, manufactured by Medical Compression Systems (Dbn) , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 29-day FDA review.

K002287 · Medical Compression Systems (Dbn) , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
29d
Days
Class 2
Risk

K002287 is an FDA 510(k) clearance for the WIZAIR COMPRESSION SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Medical Compression Systems (Dbn) , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on August 25, 2000 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002287

510(k) Number K002287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2000
Decision Date August 25, 2000
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 336
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K002287.
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
K003701 · Sentech Medical Systems, Inc. · Apr 2001
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K001802 · Microtek Medical, Inc. · Jan 2001
VASO PRESS DVT SYSTEM, MODELS VP500, VP501
K991038 · Britt Corp., Inc. · Jun 2000
PROAIR 3000 COMPRESSION SYSTEM
K993758 · Medical Compression Systems (Dbn) , Ltd. · May 2000
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
K000303 · Healthcare Service and Supply · May 2000