Cleared Traditional

GENERATOR, PULSE, CARDIAC, IMPLANTABLE (K780421) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K780421 · Telectronics, Inc. · Cardiovascular device
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Jul 1978
Decision
114d
Days
Class 3
Risk

K780421 is an FDA 510(k) clearance for the GENERATOR, PULSE, CARDIAC, IMPLANTABLE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1978 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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

Submission Details

510(k) Number K780421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1978
Decision Date July 07, 1978
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K780421.
GENERATOR, PULSE, DEMAND, MODEL 5996
K780741 · Medtronic Vascular · Jul 1978
GENERATOR, PULSE MODELS 5920/5921
K780809 · Medtronic Vascular · Jul 1978
VENTRICULAR INHIBITED PULSE GENERATOR
K780561 · Medtronic Vascular · Jul 1978
STANICOR THETA MODEL 221 CARDIAC PACER
K780453 · Cordis Corp. · Jun 1978
GENERATORS, ATRIAL INHIBITED PULSE
K780327 · Medtronic Vascular · May 1978
PACEMAKER, MODEL 252, C-MOS
K780437 · Intermedics, Inc. · Apr 1978