Cleared Traditional

BIPOLAR, STANICOR LAMBDA MODEL 236,235 (K790014) - FDA 510(k) Clearance

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

K790014 · Cordis Corp. · Cardiovascular device

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Feb 1979

Decision

36d

Days

Class 3

Risk

K790014 is an FDA 510(k) clearance for the BIPOLAR, STANICOR LAMBDA MODEL 236,235. 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 February 8, 1979 after a review of 36 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	K790014 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 03, 1979
Decision Date	February 08, 1979
Days to Decision	36 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

89d faster than avg

Panel avg: 125d · This submission: 36d

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 K790014.

OMNI-STANICOR-(THETA) MODEL 217

K790690 · Cordis Corp. · May 1979

PACEMAKERS WITHOUT SILASTIC COATING

K790764 · Telectronics, Inc. · Apr 1979

PULSE GENERATOR, IMPLANTABLE CARDIAC

K782149 · Telectronics, Inc. · Feb 1979

ISOLATION SLEEVE, MODEL 349-01

K790098 · Intermedics, Inc. · Jan 1979

ISOLATION SLEEVE, MODEL 347-01

K790099 · Intermedics, Inc. · Jan 1979

ISOLATION SLEEVE, MODEL 348-01

K790100 · Intermedics, Inc. · Jan 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 K790014

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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