Not Cleared Traditional

K965106 - ELC 35-UP MODEL NUMBER 116015 AND ELC 5...

K965106 is the FDA 510(k) submission for ELC 35-UP MODEL NUMBER 116015 AND ELC 5... by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K965106 · Biotronik, Inc. · Cardiovascular device
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Jan 1998
Decision
403d
Days
Class 3
Risk

K965106 is an FDA 510(k) submission (not cleared) for the ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Not Cleared (DENG) decision on January 27, 1998 after a review of 403 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 403 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K965106 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received December 20, 1996
Decision Date January 27, 1998
Days to Decision 403 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
278d slower than avg
Panel avg: 125d · This submission: 403d
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 352
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K965106.
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
K980869 · Biotronik, Inc. · Sep 1998
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TIR/TIJ AND POLYROX
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STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738 · Ela Medical, Inc. · May 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
K964604 · Biotronik, Inc. · Mar 1997