Cleared Traditional

K832369 - VASCULAR RECORDER #301 (FDA 510(k) Clearance)

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

K832369 · Imex Medical Systems, Inc. · Cardiovascular device
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Mar 1984
Decision
241d
Days
Class 2
Risk

K832369 is an FDA 510(k) clearance for the VASCULAR RECORDER #301. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Imex Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 241 days - an extended review cycle.

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 Imex Medical Systems, Inc. devices

Submission Details

510(k) Number K832369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1983
Decision Date March 12, 1984
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 125d · This submission: 241d
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.