Cleared Traditional

K993758 - PROAIR 3000 COMPRESSION SYSTEM

K993758 is an FDA 510(k) clearance for PROAIR 3000 COMPRESSION SYSTEM, manufactured by Medical Compression Systems (Dbn) , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K993758 · 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
May 2000
Decision
196d
Days
Class 2
Risk

K993758 is an FDA 510(k) clearance for the PROAIR 3000 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 May 19, 2000 after a review of 196 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 - K993758

510(k) Number K993758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1999
Decision Date May 19, 2000
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 336
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K993758.
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · Microtek Medical, Inc. · Jan 2001
WIZAIR COMPRESSION SYSTEM
K002287 · Medical Compression Systems (Dbn) , Ltd. · Aug 2000
VASO PRESS DVT SYSTEM, MODELS VP500, VP501
K991038 · Britt Corp., Inc. · Jun 2000
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
K000303 · Healthcare Service and Supply · May 2000
CTC DVT-1 CALF GARMENT, MODEL DVT-1
K000147 · Compression Therapy Concepts, Inc. · Apr 2000
VENAFLOW SYSTEM, MODEL 30A
K992454 · Aircast, Inc. · Jan 2000