Cleared Traditional

K910139 - VER-MED A10014 RESTING EKG ELECTRODE & A10021 (FDA 510(k) Clearance)

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

K910139 · Vermont Medical, Inc. · Cardiovascular device
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Aug 1991
Decision
213d
Days
Class 2
Risk

K910139 is an FDA 510(k) clearance for the VER-MED A10014 RESTING EKG ELECTRODE & A10021. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Vermont Medical, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on August 15, 1991 after a review of 213 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Vermont Medical, Inc. devices

Submission Details

510(k) Number K910139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1991
Decision Date August 15, 1991
Days to Decision 213 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 125d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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.