Cleared Traditional

K963159 - CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES

K963159 is an FDA 510(k) clearance for CONDUCTIVE HYDROGEL POLYMER BASED ON U ..., manufactured by Cmc Sense-It, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K963159 · Cmc Sense-It, Inc. · Cardiovascular device
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Dec 1996
Decision
119d
Days
Class 2
Risk

K963159 is an FDA 510(k) clearance for the CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Cmc Sense-It, Inc. (Hopkins, US). The FDA issued a Cleared decision on December 11, 1996 after a review of 119 days - within the typical 510(k) review window.

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 Cmc Sense-It, Inc. devices

FDA 510(k) Submission Details - K963159

510(k) Number K963159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date December 11, 1996
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 154
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K963159.
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