Cleared Traditional

K842364 - HANDHELD PACEMAKER PROGRAMMER & SOFTWAR

K842364 is the FDA 510(k) clearance for HANDHELD PACEMAKER PROGRAMMER & SOFTWAR by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code KRG) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K842364 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Sep 1984
Decision
98d
Days
Class 3
Risk

K842364 is an FDA 510(k) clearance for the HANDHELD PACEMAKER PROGRAMMER & SOFTWAR. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1984 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 870.3700 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K842364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1984
Decision Date September 24, 1984
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.

Device Classification

Product Code KRG Programmer, Pacemaker
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3700
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KRG Programmer, Pacemaker

All 17
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K842364.
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · Cardiac Pacemakers, Inc. · Sep 1986
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
K860584 · Cardiac Pacemakers, Inc. · Jun 1986
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · Pacesetter Systems · Apr 1986
PACEMAKER PROGRAMMER 2030
K820230 · Cardiac Pacemakers, Inc. · Mar 1982
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · Intermedics, Inc. · Oct 1981
PACEMAKER PROGRAMMER #2010
K811217 · Cardiac Pacemakers, Inc. · Jul 1981