Cleared Traditional

K822309 - COMMAND NP

K822309 is the FDA 510(k) clearance for COMMAND NP by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K822309 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Oct 1982
Decision
62d
Days
Class 3
Risk

K822309 is an FDA 510(k) clearance for the COMMAND NP. 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 October 4, 1982 after a review of 62 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 K822309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1982
Decision Date October 04, 1982
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K822309.
AFP PULSE GENERATOR
K823559 · Pacesetter Systems · Feb 1983
TELEMETRY DECODER #540-02
K823678 · Intermedics, Inc. · Dec 1982
ENERTRAX MODEL 7100E
K822297 · Medtronic Vascular · Oct 1982
MEDTRONIC ENERTRAX MODEL 7100
K822147 · Medtronic Vascular · Aug 1982
PROGRAMMALITH II, #225 & 226
K821003 · Pacesetter Systems · May 1982
PULSE GENERATOR 678 B
K820657 · Siemens Elema AB · Apr 1982