Cleared Traditional

K000303 - HEALTHCARE SERVICE AND SUPPLY ALP ALTER...

K000303 is an FDA 510(k) clearance for HEALTHCARE SERVICE AND SUPPLY ALP ALTER..., manufactured by Healthcare Service and Supply. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K000303 · Healthcare Service and Supply · Cardiovascular device
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May 2000
Decision
105d
Days
Class 2
Risk

K000303 is an FDA 510(k) clearance for the HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS .... Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Healthcare Service and Supply (Tustin, US). The FDA issued a Cleared decision on May 16, 2000 after a review of 105 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 Healthcare Service and Supply devices

FDA 510(k) Submission Details - K000303

510(k) Number K000303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2000
Decision Date May 16, 2000
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K000303.
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · Sterilmed, Inc. · Oct 2001
VANGUARD REPROCESSED COMPRESSION GARMENT
K012403 · Vanguard Medical Concepts, Inc. · Oct 2001
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · Microtek Medical, Inc. · Jan 2001
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · Dideco S.P.A. · Aug 1998
SOF. PRESS EPC 51 SYSTEM
K963067 · Gaymar Industries, Inc. · Jan 1997
MODEL 90022 ROLLING STAND
K963672 · Augustine Medical, Inc. · Jan 1997