Cleared Traditional

K820231 - COMMAND ULTRA I

K820231 is the FDA 510(k) clearance for COMMAND ULTRA I by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K820231 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Mar 1982
Decision
46d
Days
Class 3
Risk

K820231 is an FDA 510(k) clearance for the COMMAND ULTRA I. 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 March 15, 1982 after a review of 46 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 K820231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1982
Decision Date March 15, 1982
Days to Decision 46 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
79d faster than avg
Panel avg: 125d · This submission: 46d
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 K820231.
PULSE GENERATOR 678 B
K820657 · Siemens Elema AB · Apr 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · Intermedics, Inc. · Apr 1982
MULTICOR (GAMMA) 402 CARDIAC PACER
K820356 · Cordis Corp. · Mar 1982
COMMAND P5
K813534 · Cardiac Pacemakers, Inc. · Jan 1982
SIEMENS-ELEMA PULSE GENERATOR 659
K813576 · Siemens Elema AB · Jan 1982
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610 · Siemens Corp. · Dec 1981