Cleared Traditional

K913134 - MODEL 4220

K913134 is an FDA 510(k) clearance for MODEL 4220, 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 37-day FDA review.

K913134 · Pace Medical · Cardiovascular device
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Aug 1991
Decision
37d
Days
Class 3
Risk

K913134 is an FDA 510(k) clearance for the MODEL 4220. 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 August 22, 1991 after a review of 37 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.

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FDA 510(k) Submission Details - K913134

510(k) Number K913134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1991
Decision Date August 22, 1991
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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 K913134.
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
K920157 · Schneider Intl., Ltd. · Mar 1992
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 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
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · Intermedics, Inc. · May 1991