Cleared Traditional

MODEL 325D UNIPOLAR CARDIAC PULSE GEN (K822904) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K822904 · Cook Pacemaker Corp. · Cardiovascular device
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Oct 1982
Decision
16d
Days
Class 3
Risk

K822904 is an FDA 510(k) clearance for the MODEL 325D UNIPOLAR CARDIAC PULSE GEN. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1982 after a review of 16 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 Cook Pacemaker Corp. devices

Submission Details

510(k) Number K822904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1982
Decision Date October 15, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
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 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K822904.
MEDTRONIC MODELS 59401 5941
K823831 · Medtronic Vascular · Mar 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · Intermedics, Inc. · Mar 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
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · Intermedics, Inc. · Apr 1982