Cleared Traditional

A-V IMPULSE SYSTEM MODEL 6060 (K964425) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964425 · Powell,Goldstein,Frazer & Murphy · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
265d
Days
Class 2
Risk

K964425 is an FDA 510(k) clearance for the A-V IMPULSE SYSTEM MODEL 6060. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Powell,Goldstein,Frazer & Murphy (Washington, US). The FDA issued a Cleared decision on July 28, 1997 after a review of 265 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.

View all Powell,Goldstein,Frazer & Murphy devices

Submission Details

510(k) Number K964425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date July 28, 1997
Days to Decision 265 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
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K964425.
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
K173528 · Devon Medical Products (Jiangsu), Ltd. · Feb 2018
Medline Hemo-Force DVT Compression Sleeve
K170415 · Medline Industries, Inc. · Sep 2017
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
K163620 · Covidien · Jan 2017
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · Baxter Healthcare Corp · Jul 1991
3M BRAND TOTAL LEG COMPRESSION TLC SYS.
K791894 · 3M Company · Nov 1979