Cleared Traditional

K823371 - DURAPULSE

K823371 is an FDA 510(k) clearance for DURAPULSE, manufactured by Cpm International, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K823371 · Cpm International, Inc. · Cardiovascular device
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Dec 1982
Decision
40d
Days
Class 3
Risk

K823371 is an FDA 510(k) clearance for the DURAPULSE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cpm International, Inc. (Walker, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 40 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 Cpm International, Inc. devices

FDA 510(k) Submission Details - K823371

510(k) Number K823371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1982
Decision Date December 22, 1982
Days to Decision 40 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 125d · This submission: 40d
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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K823371.
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · Intermedics, Inc. · Mar 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639 · Pacesetter Systems · Feb 1983
AFP PULSE GENERATOR
K823559 · Pacesetter Systems · Feb 1983
TELEMETRY DECODER #540-02
K823678 · Intermedics, Inc. · Dec 1982
KALOS-03 BIPOLAR
K822907 · Biotronik Sales, Inc. · Nov 1982
MODEL 325D UNIPOLAR CARDIAC PULSE GEN
K822904 · Cook Pacemaker Corp. · Oct 1982