Cleared Traditional

K974318 - HEALTHCARE SERVICE AND SUPPLY ALP ALTER...

K974318 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 88-day FDA review.

K974318 · Healthcare Service and Supply · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
88d
Days
Class 2
Risk

K974318 is an FDA 510(k) clearance for the HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS.... 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 February 13, 1998 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Healthcare Service and Supply devices

FDA 510(k) Submission Details - K974318

510(k) Number K974318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date February 13, 1998
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K974318.
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
REDOX
K953850 · Kinetic Concepts, Inc. · Mar 1996