Cleared Traditional

K812096 - MEDTRONIC ENERTRAX MODEL 7100

K812096 is the FDA 510(k) clearance for MEDTRONIC ENERTRAX MODEL 7100 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K812096 · Medtronic Vascular · Cardiovascular device
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Sep 1981
Decision
54d
Days
Class 3
Risk

K812096 is an FDA 510(k) clearance for the MEDTRONIC ENERTRAX MODEL 7100. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on September 16, 1981 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

Submission Details

510(k) Number K812096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1981
Decision Date September 16, 1981
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.

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 K812096.
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337 · Intermedics, Inc. · Sep 1981
TELEMETRY DECODER
K801339 · Intermedics, Inc. · Sep 1981
MEDTRONIC MODEL 2409
K812580 · Medtronic Vascular · Sep 1981
MEDTRONIC SPECTRAX
K812153 · Medtronic Vascular · Aug 1981
COMMAND P5(BIPOLAR PULSE GENERATOR)
K811402 · Cardiac Pacemakers, Inc. · Jul 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887 · Ela Medical, Inc. · Jul 1981