Cleared Traditional

K792602 - SUSI II PACEMAKER SURVEILLANCE MONITOR

K792602 is the FDA 510(k) clearance for SUSI II PACEMAKER SURVEILLANCE MONITOR by Ela Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTC) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K792602 · Ela Medical, Inc. · Cardiovascular device
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Mar 1980
Decision
98d
Days
Class 2
Risk

K792602 is an FDA 510(k) clearance for the SUSI II PACEMAKER SURVEILLANCE MONITOR. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Ela Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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 Ela Medical, Inc. devices

Submission Details

510(k) Number K792602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1979
Decision Date March 25, 1980
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
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 - DTC Analyzer, Pacemaker Generator Function

All 17
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K792602.
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · Cordis Corp. · May 1985
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · Medtronic Vascular · Jun 1982
ELECTRODE/PACER SYSTEM ANALYZER PMA 400
K810604 · Telectronics, Inc. · Apr 1981
PACING SYSTEM ANALYZER PSA SCE-22
K791975 · Ela Medical, Inc. · Jan 1980
MODEL 674 PACER ANALYZER
K792074 · Del Mar Avionics · Dec 1979
SELF CHECK
K791762 · Instromedix, Inc. · Sep 1979