Cleared Traditional

K863508 - FRANTZ MEDICAL ELECTRODE

K863508 is an FDA 510(k) clearance for FRANTZ MEDICAL ELECTRODE, manufactured by Frantz Medical Development, Ltd.. The device is a Class 2 Cardiovascular device with product code DXR cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K863508 · Frantz Medical Development, Ltd. · Cardiovascular device
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Feb 1987
Decision
150d
Days
Class 2
Risk

K863508 is an FDA 510(k) clearance for the FRANTZ MEDICAL ELECTRODE. Classified as Ballistocardiograph (product code DXR), Class II - Special Controls.

Submitted by Frantz Medical Development, Ltd. (New York, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2320 - 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 Frantz Medical Development, Ltd. devices

FDA 510(k) Submission Details - K863508

510(k) Number K863508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date February 06, 1987
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXR Device Classification - Class 2, Special Controls

Product Code DXR Ballistocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2320
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.