Cleared Traditional

K912545 - MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE

K912545 is an FDA 510(k) clearance for MODEL 4205 PULSE GENERATOR SURGICAL EXT..., manufactured by Pace Medical. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K912545 · Pace Medical · Cardiovascular device
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Jul 1991
Decision
46d
Days
Class 3
Risk

K912545 is an FDA 510(k) clearance for the MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 46 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 Pace Medical devices

FDA 510(k) Submission Details - K912545

510(k) Number K912545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date July 26, 1991
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
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 K912545.
PIKOS 01 & PIKOS E 01
K914109 · Biotronik, GmbH & Co. · Feb 1992
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
K905403 · Cook Pacemaker Corp. · Oct 1991
MODEL 4220
K913134 · Pace Medical · Aug 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · Cardiac Control Systems, Inc. · May 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · Intermedics, Inc. · May 1991
TRIOS 02
K905087 · Biotronik, GmbH & Co. · May 1991