Cleared Traditional

K791920 - CARDIAC PACEMAKER P4000 SER. & P1000

K791920 is an FDA 510(k) clearance for CARDIAC PACEMAKER P4000 SER. & P1000, manufactured by Vitatron Medical BV. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K791920 · Vitatron Medical BV · Cardiovascular device
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Nov 1979
Decision
65d
Days
Class 3
Risk

K791920 is an FDA 510(k) clearance for the CARDIAC PACEMAKER P4000 SER. & P1000. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Vitatron Medical BV (Mchenry, US). The FDA issued a Cleared decision on November 29, 1979 after a review of 65 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 Vitatron Medical BV devices

FDA 510(k) Submission Details - K791920

510(k) Number K791920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1979
Decision Date November 29, 1979
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 388
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K791920.
MICROTHIN-PI
K800027 · Cardiac Pacemakers, Inc. · Jan 1980
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.
K800030 · Telectronics, Inc. · Jan 1980
IMPLANTABLE PROGRAMMABLE UNIPOLAR
K792519 · Telectronics, Inc. · Dec 1979
ARCOLITH 2100-CARDIAC PULSE GENERATOR
K792216 · Arco Medical Products Co. · Nov 1979
ARCOLITH 3020-CARDIAC PULSE GENERATOR
K792299 · Arco Medical Products Co. · Nov 1979
MEDTRONIC MODELS 5984/5985
K791316 · Medtronic Vascular · Nov 1979