Cleared Traditional

MODIFICATION OF STERILITY CYCLE PARAMETERS (K863365) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K863365 · Coratomic, Inc. · Cardiovascular device
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Oct 1986
Decision
36d
Days
Class 3
Risk

K863365 is an FDA 510(k) clearance for the MODIFICATION OF STERILITY CYCLE PARAMETERS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Coratomic, Inc. (Indiana, US). The FDA issued a Cleared decision on October 8, 1986 after a review of 36 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 Coratomic, Inc. devices

Submission Details

510(k) Number K863365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1986
Decision Date October 08, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K863365.
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · Intermedics, Inc. · Oct 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866 · Medtronic Vascular · Aug 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · Medtronic Vascular · Jan 1987
CORDIS MULTICOR II MODEL 402D PACER
K863417 · Cordis Corp. · Oct 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418 · Intermedics, Inc. · Sep 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · Medtronic Vascular · Sep 1986