Cleared Traditional

MODEL 325T PROGRAMMABLE PULSE GENERATOR (K812358) - FDA 510(k) Clearance

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

K812358 · Cook Pacemaker Corp. · Cardiovascular device
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Oct 1981
Decision
70d
Days
Class 3
Risk

K812358 is an FDA 510(k) clearance for the MODEL 325T PROGRAMMABLE PULSE GENERATOR. 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 29, 1981 after a review of 70 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 K812358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date October 29, 1981
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
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 K812358.
MEDTRONIC ENERTRAX MODEL 7100
K822147 · Medtronic Vascular · Aug 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · Intermedics, Inc. · Apr 1982
MULTICOR (GAMMA) 402 CARDIAC PACER
K820356 · Cordis Corp. · Mar 1982
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337 · Intermedics, Inc. · Sep 1981
TELEMETRY DECODER
K801339 · Intermedics, Inc. · Sep 1981
MEDTRONIC MODEL 2409
K812580 · Medtronic Vascular · Sep 1981