Cleared Traditional

K790446 - OVALITH-300

K790446 is an FDA 510(k) clearance for OVALITH-300, 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 158-day FDA review.

K790446 · Coratomic, Inc. · Cardiovascular device
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Jul 1979
Decision
158d
Days
Class 3
Risk

K790446 is an FDA 510(k) clearance for the OVALITH-300. 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 July 30, 1979 after a review of 158 days - an extended review 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 - K790446

510(k) Number K790446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1979
Decision Date July 30, 1979
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
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 K790446.
MDL-201A & T DL-201A PULSE GENERATOR
K790428 · Pacesetter Systems · Aug 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
K791225 · Shiley, Inc. · Aug 1979
ARCO PROGAMMABLE PACEMAKER SYSTEM
K791147 · Arco Medical Products Co. · Aug 1979
UNILITH PULSE GENERATOR
K791219 · Ela Medical, Inc. · Jul 1979
PULSE GENERATOR, MODEL 171
K782161 · Telectronics, Inc. · Jul 1979
BATTERY CHARGER, 171 PACEMAKER
K782162 · Telectronics, Inc. · Jul 1979