Cleared Traditional

IMPLANTABLE PULSE GENERATOR PACEMAKERS (K791568) - FDA 510(k) Clearance

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

K791568 · Intermedics, Inc. · Cardiovascular device
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Sep 1979
Decision
40d
Days
Class 3
Risk

K791568 is an FDA 510(k) clearance for the IMPLANTABLE PULSE GENERATOR PACEMAKERS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 40 days - a notably fast clearance cycle.

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 Intermedics, Inc. devices

Submission Details

510(k) Number K791568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date September 19, 1979
Days to Decision 40 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
85d faster than avg
Panel avg: 125d · This submission: 40d
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 181
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K791568.
CORDIS BIPOLAR PACER CONNECTOR SYSTEM
K791784 · Cordis Corp. · Sep 1979
IMPLANTABLE VENTRICULAR-INHIBITED
K791727 · Telectronics, Inc. · Sep 1979
PROGRAMMER, MEDTRONIC MODEL 5984/5985
K791181 · Medtronic Vascular · Sep 1979
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379 · Intermedics, Inc. · Sep 1979
IMPLANTABLE PULSE GENERATOR PACEMAKER
K791417 · Intermedics, Inc. · Sep 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
K791225 · Shiley, Inc. · Aug 1979