Cleared Traditional

K862261 - KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263 (FDA 510(k) Clearance)

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

K862261 · Kontron Instruments, Inc. · Cardiovascular device
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Feb 1987
Decision
251d
Days
Class 2
Risk

K862261 is an FDA 510(k) clearance for the KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 251 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Kontron Instruments, Inc. devices

Submission Details

510(k) Number K862261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1986
Decision Date February 19, 1987
Days to Decision 251 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 125d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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.