Cleared Traditional

LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. (K792609) - FDA 510(k) Clearance

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

K792609 · Medcor, Inc. · Cardiovascular device
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Nov 1980
Decision
337d
Days
Class 3
Risk

K792609 is an FDA 510(k) clearance for the LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN.. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medcor, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 19, 1980 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Medcor, Inc. devices

Submission Details

510(k) Number K792609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1979
Decision Date November 19, 1980
Days to Decision 337 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 125d · This submission: 337d
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 K792609.
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386 · Intermedics, Inc. · Mar 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584 · Medtronic Vascular · Feb 1981
CYBERLITH PROGRAMMER
K801338 · Intermedics, Inc. · Jan 1981
MEDTRONIC MODEL 2409
K800226 · Medtronic Vascular · Sep 1980
INSULATING SHEATH
K801910 · Cordis Corp. · Sep 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · Intermedics, Inc. · Sep 1980