Cleared Traditional

K902134 - MINIX, MINIX ST, NEW IC: L74

K902134 is an FDA 510(k) clearance for MINIX, manufactured by Medtronic Vascular. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K902134 · Medtronic Vascular · Cardiovascular device
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Jul 1990
Decision
54d
Days
Class 3
Risk

K902134 is an FDA 510(k) clearance for the MINIX, MINIX ST, NEW IC: L74. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 54 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K902134

510(k) Number K902134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1990
Decision Date July 03, 1990
Days to Decision 54 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
71d faster than avg
Panel avg: 125d · This submission: 54d
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 K902134.
IMPLANTABLE PULSE DEVICES
K903919 · Medtronic Vascular · Oct 1990
NEOS (TM) 02 B PULSE GENERATOR
K903081 · Biotronik, GmbH & Co. · Sep 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
K901535 · Medtronic Vascular · Jul 1990
MODIFIED MODEL 5401B TEST CABLE
K900622 · Medtronic Vascular · Apr 1990
OPTIMA MPT MODEL 5281E AND MODEL 5282E
K897116 · Telectronics Pacing Systems, Inc. · Mar 1990
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461 · Ela Medical, Inc. · Mar 1990