Cleared Traditional

K811123 - MEDTRONIC PULSE GENERATOR

K811123 is the FDA 510(k) clearance for MEDTRONIC PULSE GENERATOR by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K811123 · Medtronic Vascular · Cardiovascular device
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May 1981
Decision
33d
Days
Class 3
Risk

K811123 is an FDA 510(k) clearance for the MEDTRONIC PULSE GENERATOR. 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 May 27, 1981 after a review of 33 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 K811123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1981
Decision Date May 27, 1981
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 K811123.
ELA MEDICAL UNILITH PULSE GENERATOR
K810142 · Ela Medical, Inc. · May 1981
MULTILITH PULSE GENERATOR #1140
K810489 · Ela Medical, Inc. · May 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677 · Medtronic, Inc. · May 1981
INTERMEDICS CYBERLITH BIPOLAR CARDIAC
K811221 · Intermedics, Inc. · May 1981
MODELS 8420 THRU 8423 PACEMAKER GENER
K810734 · Medtronic Vascular · May 1981
THINLITH III UNIPOLAR CARDIAC PULSE GEN.
K810752 · Intermedics, Inc. · May 1981