Cleared Traditional

CORATOMIC MODEL OVALITH-920 (K810808) - FDA 510(k) Clearance

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

K810808 · Coratomic, Inc. · Cardiovascular device
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May 1981
Decision
52d
Days
Class 3
Risk

K810808 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 15, 1981 after a review of 52 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 K810808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date May 15, 1981
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
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 K810808.
MEDTRONIC PULSE GENERATOR
K811123 · Medtronic Vascular · 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
MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
K810800 · Intermedics, Inc. · May 1981
MODEL 230-06 CYBERLITH TM I BIPOLAR IN
K811066 · Intermedics, Inc. · May 1981