Cleared Traditional

K791419 - OMNICOR PROGRAMMER MODEL 222C

K791419 is an FDA 510(k) clearance for OMNICOR PROGRAMMER MODEL 222C, manufactured by Cordis Corp.. The device is a Class 3 Cardiovascular device with product code KRG cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K791419 · Cordis Corp. · Cardiovascular device
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Nov 1979
Decision
133d
Days
Class 3
Risk

K791419 is an FDA 510(k) clearance for the OMNICOR PROGRAMMER MODEL 222C. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 133 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 Cordis Corp. devices

FDA 510(k) Submission Details - K791419

510(k) Number K791419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1979
Decision Date November 27, 1979
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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 K791419.
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K810552 · Cordis Corp. · Mar 1981
EPR-200 PROGRAMMER MODEL 010
K800376 · Biotronik Sales, Inc. · Apr 1980
PACEMAKER PROGRAMMER
K792580 · Cardiac Pacemakers, Inc. · Dec 1979
PACEMAKER PROGRAMMER
K790220 · Intermedics, Inc. · Jul 1979
RATE PROGRAMMER MODEL 520
K780175 · Intermedics, Inc. · Apr 1978
OMNICOR PROGRAMMER MODEL 222A
K771855 · Cordis Corp. · Oct 1977