Cleared Traditional

ZIPPREP ELECTRODE (K940802) - FDA 510(k) Clearance

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

K940802 · Aspect Medical Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
120d
Days
Class 2
Risk

K940802 is an FDA 510(k) clearance for the ZIPPREP ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Framingham, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 120 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 Aspect Medical Systems, Inc. devices

Submission Details

510(k) Number K940802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date June 22, 1994
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
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.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 328
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