Cleared Traditional

OMNI-STANICOR (THETA) MOD 237A (K791783) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K791783 · Cordis Corp. · Cardiovascular device

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Oct 1979

Decision

41d

Days

Class 3

Risk

K791783 is an FDA 510(k) clearance for the OMNI-STANICOR (THETA) MOD 237A. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1979 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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

Submission Details

510(k) Number	K791783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 11, 1979
Decision Date	October 22, 1979
Days to Decision	41 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

84d faster than avg

Panel avg: 125d · This submission: 41d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	DXY Implantable Pacemaker Pulse-generator
Device Class	Class 3 - Premarket Approval
CFR Regulation	21 CFR 870.3610

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 - DXY Implantable Pacemaker Pulse-generator

All 181

Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K791783.

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.

K800030 · Telectronics, Inc. · Jan 1980

IMPLANTABLE PROGRAMMABLE UNIPOLAR

K792519 · Telectronics, Inc. · Dec 1979

MEDTRONIC MODELS 5984/5985

K791316 · Medtronic Vascular · Nov 1979

IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD

K792052 · Telectronics, Inc. · Oct 1979

PULSE GENERATORS, MODELS 5983, 5989

K790068 · Medtronic Vascular · Sep 1979

CORDIS BIPOLAR PACER CONNECTOR SYSTEM

K791784 · Cordis Corp. · Sep 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K791783

Cordis Corp.

Mchenry, IL · US

Regulatory profile

315 submissions 281 cleared

89% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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