Cleared Traditional

K791921 - CARDIAC PACEMAKER C4000

K791921 is an FDA 510(k) clearance for CARDIAC PACEMAKER C4000, 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 31-day FDA review.

K791921 · Vitatron Medical BV · Cardiovascular device
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Oct 1979
Decision
31d
Days
Class 3
Risk

K791921 is an FDA 510(k) clearance for the CARDIAC PACEMAKER C4000, C1000 SER.. 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 October 26, 1979 after a review of 31 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 - K791921

510(k) Number K791921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1979
Decision Date October 26, 1979
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
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 K791921.
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
OMNI-STANICOR (THETA) MOD 237A
K791783 · Cordis Corp. · Oct 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD
K792052 · Telectronics, Inc. · Oct 1979
PULSE GENERATORS, MODELS 5983, 5989
K790068 · Medtronic Vascular · Sep 1979