Cleared Traditional

K781823 - ELECTRODE

K781823 is an FDA 510(k) clearance for ELECTRODE, 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 104-day FDA review.

K781823 · Telectronics, Inc. · Cardiovascular device
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Feb 1979
Decision
104d
Days
Class 2
Risk

K781823 is an FDA 510(k) clearance for the ELECTRODE, MODEL 030-326. 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 February 8, 1979 after a review of 104 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 - K781823

510(k) Number K781823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1978
Decision Date February 08, 1979
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K781823.
ADAPTER KIT
K800353 · Daig Corp. · May 1980
BIPOLAR LEAD ADAPTOR, MODEL BA-415
K790218 · Pacesetter Systems · Aug 1979
ELECTRODE, MODEL 030-324
K781822 · Telectronics, Inc. · Feb 1979
ELECTRODE, MODEL 030-324/4 GUAGE
K781824 · Telectronics, Inc. · Feb 1979
ELECTRODE LEAD MODEL 030-198
K782097 · Telectronics, Inc. · Dec 1978
ADAPTER KIT
K781864 · Daig Corp. · Dec 1978