Cleared Traditional

K896809 - MEDTRONIC SPECTRAX SXT MODEL 8423M PULS...

K896809 is the FDA 510(k) clearance for MEDTRONIC SPECTRAX SXT MODEL 8423M PULS... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K896809 · Medtronic Vascular · Cardiovascular device
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Jan 1990
Decision
53d
Days
Class 3
Risk

K896809 is an FDA 510(k) clearance for the MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR. 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 January 26, 1990 after a review of 53 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 K896809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date January 26, 1990
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 K896809.
MINIX, MINIX ST, NEW IC: L74
K902134 · Medtronic Vascular · Jul 1990
MODIFIED MODEL 5401B TEST CABLE
K900622 · Medtronic Vascular · Apr 1990
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461 · Ela Medical, Inc. · Mar 1990
OPUS MODEL 4001
K894065 · Ela Medical, Inc. · Sep 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · Medtronic Vascular · Sep 1989
OPUS MODELS 4033 AND 4034
K894267 · Ela Medical, Inc. · Sep 1989