Cleared Traditional

K812832 - MODEL 325C UNIPOLAR CARDIAC PULSE GEN.

K812832 is the FDA 510(k) clearance for MODEL 325C UNIPOLAR CARDIAC PULSE GEN. by Cook Pacemaker Corp.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K812832 · Cook Pacemaker Corp. · Cardiovascular device
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Nov 1981
Decision
27d
Days
Class 3
Risk

K812832 is an FDA 510(k) clearance for the MODEL 325C 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 November 5, 1981 after a review of 27 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 K812832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1981
Decision Date November 05, 1981
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K812832.
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610 · Siemens Corp. · Dec 1981
BIPOLAR OPTIMA MP #255
K813079 · Telectronics, Inc. · Dec 1981
DIRECTIONAL BOOT
K813150 · Pacesetter Systems · Dec 1981
MODEL 325T PROGRAMMABLE PULSE GENERATOR
K812358 · Cook Pacemaker Corp. · Oct 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K812790 · Telectronics, Inc. · Oct 1981
KALOS-03
K812218 · Biotronik Sales, Inc. · Oct 1981