Cleared Traditional

K840026 - IMPLANTABLE ELECTRODE UNIPOLAR ADAPT

K840026 is an FDA 510(k) clearance for IMPLANTABLE ELECTRODE UNIPOLAR ADAPT, manufactured by Telectronics, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K840026 · Telectronics, Inc. · Cardiovascular device
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May 1984
Decision
139d
Days
Class 2
Risk

K840026 is an FDA 510(k) clearance for the IMPLANTABLE ELECTRODE UNIPOLAR ADAPT. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Standard predicate-based submission. Standard predicate reliance. 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 - K840026

510(k) Number K840026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1984
Decision Date May 23, 1984
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 85
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K840026.
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · Pacesetter Systems · Aug 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · Pacesetter Systems · Aug 1984
IMPLANTABLE ELECTRODE BIPOLAR ADAPT
K840025 · Telectronics, Inc. · May 1984
LEAD ADAPTERS #'S 6016,6022,6017 ETC
K831160 · Cardiac Pacemakers, Inc. · May 1983
MODEL 366-07 ADAPT AID LEAD ADAPTER
K822704 · Intermedics, Inc. · Nov 1982
PACEMAKER UNIPOLAR ADAPTER
K821547 · Pacesetter Systems · Jun 1982