Cleared Traditional

K782097 - ELECTRODE LEAD MODEL 030-198

K782097 is an FDA 510(k) clearance for ELECTRODE LEAD MODEL 030-198, 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 4-day FDA review.

K782097 · Telectronics, Inc. · Cardiovascular device
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Dec 1978
Decision
4d
Days
Class 2
Risk

K782097 is an FDA 510(k) clearance for the ELECTRODE LEAD MODEL 030-198. 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 December 22, 1978 after a review of 4 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Telectronics, Inc. devices

FDA 510(k) Submission Details - K782097

510(k) Number K782097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1978
Decision Date December 22, 1978
Days to Decision 4 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
121d faster than avg
Panel avg: 125d · This submission: 4d
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 K782097.
ELECTRODE, MODEL 030-324
K781822 · Telectronics, Inc. · Feb 1979
ELECTRODE, MODEL 030-326
K781823 · Telectronics, Inc. · Feb 1979
ELECTRODE, MODEL 030-324/4 GUAGE
K781824 · Telectronics, Inc. · Feb 1979
ADAPTER KIT
K781864 · Daig Corp. · Dec 1978
LEAD ADAPTOR KIT MODEL 5866-21
K772058 · Medtronic Vascular · Nov 1977
UNIVERSAL LEAD ADAPTER, UA-414
K771641 · Pacesetter Systems · Sep 1977