Cleared Traditional

K792602 - SUSI II PACEMAKER SURVEILLANCE MONITOR

K792602 is an FDA 510(k) clearance for SUSI II PACEMAKER SURVEILLANCE MONITOR, manufactured by Ela Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K792602

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.

DTC Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K792602.
TELECTRONICS MODEL 2401
K831697 · Seamed Corp. · Sep 1984
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