Cleared Traditional

K790566 - PACEMAKER, OVALITH-D CARDIAC

K790566 is an FDA 510(k) clearance for PACEMAKER, manufactured by Caratomic. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway .

K790566 · Caratomic · Cardiovascular device
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Mar 1979
Decision
-
Days
Class 3
Risk

K790566 is an FDA 510(k) clearance for the PACEMAKER, OVALITH-D CARDIAC. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Caratomic (Mchenry, US). The FDA issued a Cleared decision on March 19, 1979.

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 Caratomic devices

FDA 510(k) Submission Details - K790566

510(k) Number K790566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received March 19, 1979
Decision Date March 19, 1979
Days to Decision -
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
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 K790566.
PULSE GENERATOR MODEL 61 AND 128
K790562 · Ela Medical, Inc. · May 1979
PACEMAKERS WITHOUT SILASTIC COATING
K790764 · Telectronics, Inc. · Apr 1979
MICROLITH MODELS 505
K790432 · Cardiac Pacemakers, Inc. · Mar 1979
MINILITH AND MICROLITH
K790276 · Cardiac Pacemakers, Inc. · Feb 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · Telectronics, Inc. · Feb 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014 · Cordis Corp. · Feb 1979