Cleared Traditional

K811402 - COMMAND P5(BIPOLAR PULSE GENERATOR)

K811402 is the FDA 510(k) clearance for COMMAND P5(BIPOLAR PULSE GENERATOR) by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K811402 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jul 1981
Decision
70d
Days
Class 3
Risk

K811402 is an FDA 510(k) clearance for the COMMAND P5(BIPOLAR PULSE GENERATOR). Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981 after a review of 70 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K811402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1981
Decision Date July 27, 1981
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 279
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K811402.
MEDTRONIC MODEL 2409
K812580 · Medtronic Vascular · Sep 1981
MEDTRONIC ENERTRAX MODEL 7100
K812096 · Medtronic Vascular · Sep 1981
MEDTRONIC SPECTRAX
K812153 · Medtronic Vascular · Aug 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691 · Cordis Corp. · Jul 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350 · Medtronic Vascular · Jul 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677 · Medtronic, Inc. · May 1981