Cleared Traditional

K812813 - INTERMEDICS PROGRAMMER

K812813 is an FDA 510(k) clearance for INTERMEDICS PROGRAMMER, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code KRG cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K812813 · Intermedics, Inc. · Cardiovascular device
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Oct 1981
Decision
21d
Days
Class 3
Risk

K812813 is an FDA 510(k) clearance for the INTERMEDICS PROGRAMMER, MODEL 522-03. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1981 after a review of 21 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K812813

510(k) Number K812813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date October 27, 1981
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

KRG Device Classification - Class 3, Premarket Approval

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 18
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K812813.
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
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HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · Cardiac Pacemakers, Inc. · Sep 1984
PACEMAKER PROGRAMMER 2030
K820230 · Cardiac Pacemakers, Inc. · Mar 1982
PACEMAKER PROGRAMMER #2010
K811217 · Cardiac Pacemakers, Inc. · Jul 1981
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K810552 · Cordis Corp. · Mar 1981
EPR-200 PROGRAMMER MODEL 010
K800376 · Biotronik Sales, Inc. · Apr 1980