Cleared Traditional

K811217 - PACEMAKER PROGRAMMER #2010

K811217 is the FDA 510(k) clearance for PACEMAKER PROGRAMMER #2010 by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code KRG) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K811217 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jul 1981
Decision
77d
Days
Class 3
Risk

K811217 is an FDA 510(k) clearance for the PACEMAKER PROGRAMMER #2010. 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 July 20, 1981 after a review of 77 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K811217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date July 20, 1981
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K811217.
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · Cardiac Pacemakers, Inc. · Sep 1984
PACEMAKER PROGRAMMER 2030
K820230 · Cardiac Pacemakers, Inc. · Mar 1982
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · Intermedics, Inc. · Oct 1981
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K810552 · Cordis Corp. · Mar 1981
PACEMAKER PROGRAMMER
K792580 · Cardiac Pacemakers, Inc. · Dec 1979
OMNICOR PROGRAMMER MODEL 222C
K791419 · Cordis Corp. · Nov 1979