Cleared Traditional

K905403 - MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER

K905403 is an FDA 510(k) clearance for MODEL 340 SERIES UNIPOLAR & MODEL 5000B..., manufactured by Cook Pacemaker Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K905403 · Cook Pacemaker Corp. · Cardiovascular device
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Oct 1991
Decision
317d
Days
Class 3
Risk

K905403 is an FDA 510(k) clearance for the MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on October 16, 1991 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K905403

510(k) Number K905403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date October 16, 1991
Days to Decision 317 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
192d slower than avg
Panel avg: 125d · This submission: 317d
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 K905403.
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PIKOS 01 & PIKOS E 01
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MODEL 4220
K913134 · Pace Medical · Aug 1991
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
K912545 · Pace Medical · Jul 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · Cardiac Control Systems, Inc. · May 1991