Cleared Traditional

K904892 - VACUUM BAKE CYCLE

K904892 is the FDA 510(k) clearance for VACUUM BAKE CYCLE by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K904892 · Medtronic Vascular · Cardiovascular device
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Dec 1990
Decision
51d
Days
Class 3
Risk

K904892 is an FDA 510(k) clearance for the VACUUM BAKE CYCLE. 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 December 20, 1990 after a review of 51 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

Submission Details

510(k) Number K904892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date December 20, 1990
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K904892.
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
K905403 · Cook Pacemaker Corp. · Oct 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · Intermedics, Inc. · May 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602 · Medtronic Vascular · Jan 1991
IMPLANTABLE PULSE DEVICES
K903919 · Medtronic Vascular · Oct 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
K901535 · Medtronic Vascular · Jul 1990
MINIX, MINIX ST, NEW IC: L74
K902134 · Medtronic Vascular · Jul 1990