Cleared Traditional

K974318 - HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB

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
Combination Product No
PCCP Authorized No
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 326
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K974318.
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · Dideco S.P.A. · Aug 1998
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
K971892 · Biomedical Horizons, Inc. · Aug 1998
JOBST ATHROMBIC PUMP SYSTEM 2600
K980456 · Jobst A Beiersdorf Co. · May 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · Huntleigh Healthcare, Inc. · Jan 1998
JOBST ATHROMBIC PUMP/SLEEVE
K970922 · Jobst A Beiersdorf Co. · Jan 1998
TRINITY DVT SYSTEM
K963957 · Delphi Consulting Group · Nov 1997