Cleared Traditional

K832110 - ELECTRODE LEADS 030-267 & 030-268

K832110 is an FDA 510(k) clearance for ELECTRODE LEADS 030-267 & 030-268, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K832110 · Telectronics, Inc. · Cardiovascular device
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Aug 1983
Decision
43d
Days
Class 3
Risk

K832110 is an FDA 510(k) clearance for the ELECTRODE LEADS 030-267 & 030-268. 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 August 12, 1983 after a review of 43 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

FDA 510(k) Submission Details - K832110

510(k) Number K832110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date August 12, 1983
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 387
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K832110.
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108 · Biotronik Sales, Inc. · Oct 1983
UNIPOLAR-E ENDOCARDIAL TINED LEAD
K832245 · Cook Pacemaker Corp. · Aug 1983
MODEL F UNIPOLAR ENDOCARDIAL LEAD-
K832255 · Cook Pacemaker Corp. · Aug 1983
LIFELINE PACING LEADS #471-07 &09
K832409 · Intermedics, Inc. · Aug 1983