Cleared Traditional

K800696 - ELECTRONIC PACEMAKER WAVEFORM ANALYZER

K800696 is an FDA 510(k) clearance for ELECTRONIC PACEMAKER WAVEFORM ANALYZER, manufactured by Instromedix, Inc.. The device is a Class 2 Cardiovascular device with product code KRE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K800696 · Instromedix, Inc. · Cardiovascular device
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Aug 1980
Decision
139d
Days
Class 2
Risk

K800696 is an FDA 510(k) clearance for the ELECTRONIC PACEMAKER WAVEFORM ANALYZER. Classified as Analyzer, Pacemaker Generator Function, Indirect (product code KRE), Class II - Special Controls.

Submitted by Instromedix, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1980 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3640 - 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.

FDA 510(k) Submission Details - K800696

510(k) Number K800696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1980
Decision Date August 14, 1980
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRE Device Classification - Class 2, Special Controls

Product Code KRE Analyzer, Pacemaker Generator Function, Indirect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3640
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 - KRE Analyzer, Pacemaker Generator Function, Indirect

All 12
Devices cleared under the same product code (KRE) and FDA review panel - the closest regulatory comparables to K800696.
PACEMAKER SYS ANALYZER #384
K833647 · Pacesetter Systems · Dec 1983
PACEMAKER SYS. ANALYZER 378
K832959 · Siemens Elema AB · Nov 1983
CARDIOMEMO
K803286 · Instromedix, Inc. · Mar 1981
ULTRA-CHEK PACEMAKER MONITOR
K801022 · Powers Medical Systmes · Jun 1980
PACE-PULSE/COMPUTRAC
K800782 · Bib, Inc. · May 1980
K800696 · ELECTRONIC PACEMAKER WAVEFORM ANALYZER
Download PDF Instromedix, Inc.