Cleared Traditional

K823934 - CARIEL F12

K823934 is an FDA 510(k) clearance for CARIEL F12, manufactured by Odam. The device is a Class 2 Cardiovascular device with product code DYC cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K823934 · Odam · Cardiovascular device
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Dec 1983
Decision
352d
Days
Class 2
Risk

K823934 is an FDA 510(k) clearance for the CARIEL F12. Classified as Vectorcardiograph (product code DYC), Class II - Special Controls.

Submitted by Odam (France, FR). The FDA issued a Cleared decision on December 16, 1983 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2400 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K823934

510(k) Number K823934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1982
Decision Date December 16, 1983
Days to Decision 352 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 125d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYC Device Classification - Class 2, Special Controls

Product Code DYC Vectorcardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2400
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.