Cleared Traditional

K792580 - PACEMAKER PROGRAMMER

K792580 is the FDA 510(k) clearance for PACEMAKER PROGRAMMER by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code KRG) cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K792580 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Dec 1979
Decision
5d
Days
Class 3
Risk

K792580 is an FDA 510(k) clearance for the PACEMAKER PROGRAMMER. 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 December 19, 1979 after a review of 5 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 K792580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1979
Decision Date December 19, 1979
Days to Decision 5 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
120d faster than avg
Panel avg: 125d · This submission: 5d
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 K792580.
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · Intermedics, Inc. · Oct 1981
PACEMAKER PROGRAMMER #2010
K811217 · Cardiac Pacemakers, Inc. · Jul 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
RATE PROGRAMMER MODEL 520
K780175 · Intermedics, Inc. · Apr 1978