Cleared Traditional

EASI LEAD SYSTEM CABLE ASSEMBLY (K872781) - FDA 510(k) Clearance

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

K872781 · Totemite Medical Electronics · Cardiovascular device
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Dec 1987
Decision
168d
Days
Class 2
Risk

K872781 is an FDA 510(k) clearance for the EASI LEAD SYSTEM CABLE ASSEMBLY. Classified as Adaptor, Lead Switching, Electrocardiograph (product code DRW), Class II - Special Controls.

Submitted by Totemite Medical Electronics (Blaine, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2350 - 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.

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Submission Details

510(k) Number K872781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date December 29, 1987
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRW Adaptor, Lead Switching, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2350
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.