Cleared Traditional

K791975 - PACING SYSTEM ANALYZER PSA SCE-22

K791975 is the FDA 510(k) clearance for PACING SYSTEM ANALYZER PSA SCE-22 by Ela Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTC) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K791975 · Ela Medical, Inc. · Cardiovascular device
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Jan 1980
Decision
121d
Days
Class 2
Risk

K791975 is an FDA 510(k) clearance for the PACING SYSTEM ANALYZER PSA SCE-22. 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 January 31, 1980 after a review of 121 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 K791975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1979
Decision Date January 31, 1980
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K791975.
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · Medtronic Vascular · Jun 1982
ELECTRODE/PACER SYSTEM ANALYZER PMA 400
K810604 · Telectronics, Inc. · Apr 1981
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602 · Ela Medical, Inc. · Mar 1980
MODEL 674 PACER ANALYZER
K792074 · Del Mar Avionics · Dec 1979
SELF CHECK
K791762 · Instromedix, Inc. · Sep 1979
PACER-TRACER PULSE WIDTH
K781349 · Instromedix, Inc. · Aug 1978