Cleared Traditional

K821033 - CORATOMIC MODEL OVALITH-920

K821033 is an FDA 510(k) clearance for CORATOMIC MODEL OVALITH-920, manufactured by Coratomic, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K821033 · Coratomic, Inc. · Cardiovascular device
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May 1982
Decision
45d
Days
Class 3
Risk

K821033 is an FDA 510(k) clearance for the CORATOMIC MODEL OVALITH-920. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Coratomic, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 45 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

FDA 510(k) Submission Details - K821033

510(k) Number K821033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1982
Decision Date May 28, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K821033.
COMMAND NP
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JAIN INSULATING BOOT MODEL 225B
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MEDTRONIC ENERTRAX MODEL 7100
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PROGRAMMALITH II, #225 & 226
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PULSE GENERATOR
K821073 · Biotronik Sales, Inc. · May 1982
COOK #326T PROGRAM/TELEMETRY BIPOLAR
K821147 · Cook Pacemaker Corp. · May 1982