Cleared Traditional

K831216 - COMMAND ULTRA II

K831216 is an FDA 510(k) clearance for COMMAND ULTRA II, manufactured by Cardiac Pacemakers, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K831216 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jul 1983
Decision
89d
Days
Class 3
Risk

K831216 is an FDA 510(k) clearance for the COMMAND ULTRA II. 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 12, 1983 after a review of 89 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

FDA 510(k) Submission Details - K831216

510(k) Number K831216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1983
Decision Date July 12, 1983
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K831216.
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI
K832893 · Cook Pacemaker Corp. · Oct 1983
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN
K831771 · Telectronics, Inc. · Aug 1983
MODEL 327T UNIPOLAR CARDIAC PULSE GEN
K832052 · Cook Pacemaker Corp. · Aug 1983
COMMAND ULTRA I
K831161 · Cardiac Pacemakers, Inc. · Jun 1983
NEDS-01 & EPR-500
K830862 · Biotronik Sales, Inc. · May 1983
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
K823878 · Pacesetter Systems · Mar 1983