Cleared Traditional

K863046 - ULTRA SOFTWARE MODULE: MODEL 2016

K863046 is the FDA 510(k) clearance for ULTRA SOFTWARE MODULE: MODEL 2016 by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code KRG) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K863046 · Cardiac Pacemakers, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
115d
Days
Class 3
Risk

K863046 is an FDA 510(k) clearance for the ULTRA SOFTWARE MODULE: MODEL 2016. 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 December 5, 1986 after a review of 115 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 K863046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date December 05, 1986
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 K863046.
MODEL 2331T PATIENT PROGRAMMER
K880738 · Medtronic Vascular · Nov 1988
MODEL 1740 PERSONAL POCKET PROGRAMMER
K864712 · Telectronics, Inc. · Dec 1987
MODEL 5600B PROGRAMMER, PACEMAKER
K871986 · Telectronics, Inc. · Jun 1987
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