Cleared Traditional

K831303 - TELECTRONICS #030-253 BIFURCATED

K831303 is an FDA 510(k) clearance for TELECTRONICS #030-253 BIFURCATED, manufactured by William C. Nealon. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K831303 · William C. Nealon · Cardiovascular device
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May 1983
Decision
34d
Days
Class 3
Risk

K831303 is an FDA 510(k) clearance for the TELECTRONICS #030-253 BIFURCATED. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by William C. Nealon (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 34 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 William C. Nealon devices

FDA 510(k) Submission Details - K831303

510(k) Number K831303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1983
Decision Date May 25, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
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 424
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K831303.
CCS MODEL SJ-103 IMPLANTABLE ATRIAL
K831529 · Cardiac Control Systems, Inc. · Jun 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · Pacesetter Systems · Jun 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436 · Pacesetter Systems · Jun 1983
POROUS TIP ENDOCARDIAL LEAD
K830743 · Daig Corp. · May 1983
MODEL JY PACEMAKER LEAD - VARIOUS
K823889 · Oscor, Inc. · Apr 1983
MODEL MZ PACEMAKER LEAD-VARIOUS
K823893 · Oscor, Inc. · Apr 1983