Cleared Traditional

ELECTRODE LEAD OF SILICONE ELASTOMETER (K823452) - FDA 510(k) Clearance

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

K823452 · Telectronics, Inc. · Cardiovascular device
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Jan 1983
Decision
52d
Days
Class 3
Risk

K823452 is an FDA 510(k) clearance for the ELECTRODE LEAD OF SILICONE ELASTOMETER. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1983 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Telectronics, Inc. devices

Submission Details

510(k) Number K823452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1982
Decision Date January 08, 1983
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K823452.
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782 · Intermedics, Inc. · Apr 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463 · Intermedics, Inc. · Feb 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508 · Intermedics, Inc. · Jan 1983
MEDTRONIC MODELS 4011 & 4511
K822781 · Medtronic Vascular · Nov 1982
MEDTRONIC #6993
K820989 · Medtronic Vascular · Aug 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · Cordis Corp. · Aug 1982