Cleared Traditional

THE CIRCULATOR BOOT (K971026) - FDA 510(k) Clearance

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

K971026 · Circulator Boot Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
147d
Days
Class 2
Risk

K971026 is an FDA 510(k) clearance for the THE CIRCULATOR BOOT. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Circulator Boot Corp. (Ardmore, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - 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 Circulator Boot Corp. devices

Submission Details

510(k) Number K971026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1997
Decision Date August 14, 1997
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRN Device, Counter-pulsating, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5225
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 - DRN Device, Counter-pulsating, External

All 33
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