Cleared Traditional

K833619 - CONDUCTANCE METER

K833619 is an FDA 510(k) clearance for CONDUCTANCE METER, manufactured by Circadian, Inc.. The device is a Class 2 Cardiovascular device with product code KRC cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K833619 · Circadian, Inc. · Cardiovascular device
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Jan 1984
Decision
105d
Days
Class 2
Risk

K833619 is an FDA 510(k) clearance for the CONDUCTANCE METER. Classified as Tester, Electrode, Surface, Electrocardiographic (product code KRC), Class II - Special Controls.

Submitted by Circadian, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2370 - 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 Circadian, Inc. devices

FDA 510(k) Submission Details - K833619

510(k) Number K833619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date January 27, 1984
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRC Device Classification - Class 2, Special Controls

Product Code KRC Tester, Electrode, Surface, Electrocardiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2370
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.