Cleared Traditional

K961582 - EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100

K961582 is an FDA 510(k) clearance for EXTERNAL PACEMAKER ANALYZER, manufactured by North American Technical Services Corp.. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K961582 · North American Technical Services Corp. · Cardiovascular device
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Nov 1996
Decision
198d
Days
Class 2
Risk

K961582 is an FDA 510(k) clearance for the EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by North American Technical Services Corp. (Sound Beach, US). The FDA issued a Cleared decision on November 8, 1996 after a review of 198 days - an extended review cycle.

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 North American Technical Services Corp. devices

FDA 510(k) Submission Details - K961582

510(k) Number K961582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date November 08, 1996
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
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 K961582.
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MODEL 5311B A-V PACING SYSTEM ANALYZER
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CPI MODEL 2215/SEAMED MODEL 3400
K910223 · Seamed Corp. · Mar 1991