Cleared Traditional

DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (K860546) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K860546 · Pacesetter Systems · Cardiovascular device
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Apr 1986
Decision
69d
Days
Class 3
Risk

K860546 is an FDA 510(k) clearance for the DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 69 days - a notably fast clearance cycle.

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 Pacesetter Systems devices

Submission Details

510(k) Number K860546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1986
Decision Date April 23, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
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 24
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K860546.
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
K933278 · Intermedics, Inc. · Mar 1995
MODEL 2331T PATIENT PROGRAMMER
K880738 · Medtronic Vascular · Nov 1988
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · Intermedics, Inc. · Oct 1981
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K810552 · Cordis Corp. · Mar 1981
OMNICOR PROGRAMMER MODEL 222C
K791419 · Cordis Corp. · Nov 1979
PACEMAKER PROGRAMMER
K790220 · Intermedics, Inc. · Jul 1979