Cleared Traditional

K860579 - CARDIOSCAN DOPPLER OPTION (FDA 510(k) Clearance)

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

K860579 · Interspec, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
132d
Days
Class 2
Risk

K860579 is an FDA 510(k) clearance for the CARDIOSCAN DOPPLER OPTION. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Interspec, Inc. (Conshohocken, US). The FDA issued a Cleared decision on June 30, 1986 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 Interspec, Inc. devices

Submission Details

510(k) Number K860579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1986
Decision Date June 30, 1986
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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.