Cleared Traditional

K000303 - HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 326
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K000303.
WIZAIR COMPRESSION SYSTEM
K002287 · Medical Compression Systems (Dbn) , Ltd. · Aug 2000
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
CTC DVT-1 CALF GARMENT, MODEL DVT-1
K000147 · Compression Therapy Concepts, Inc. · Apr 2000
VENAFLOW SYSTEM, MODEL 30A
K992454 · Aircast, Inc. · Jan 2000
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · The Kendall Company, L.P. · Sep 1999