Cleared Traditional

K860584 - SOFTWARE MODULE/2035 PROG AND ASTRA/T P...

K860584 is the FDA 510(k) clearance for SOFTWARE MODULE/2035 PROG AND ASTRA/T P... by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code KRG) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K860584 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jun 1986
Decision
108d
Days
Class 3
Risk

K860584 is an FDA 510(k) clearance for the SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 6, 1986 after a review of 108 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 K860584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1986
Decision Date June 06, 1986
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 K860584.
MODEL 5600B PROGRAMMER, PACEMAKER
K871986 · Telectronics, Inc. · Jun 1987
ULTRA SOFTWARE MODULE: MODEL 2016
K863046 · Cardiac Pacemakers, Inc. · Dec 1986
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · Cardiac Pacemakers, Inc. · Sep 1986
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · Pacesetter Systems · Apr 1986
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · Cardiac Pacemakers, Inc. · Sep 1984
PACEMAKER PROGRAMMER 2030
K820230 · Cardiac Pacemakers, Inc. · Mar 1982