Omnicor Programmer Model 222A

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K771855 ↗

FDA product code

KRG

Device class

Class III

Regulation

21 CFR Part 870.3700

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

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See all devices from Cordis US Corp. →

• What clinical setting is the Omnicor Programmer Model 222A intended for use in, and how does it interact with pacemakers?

  The Omnicor Programmer Model 222A is designed exclusively for hospital or clinical electrophysiology laboratories. It interfaces directly with compatible implantable pacemaker models to allow clinicians to adjust pacing parameters, test device functionality, and troubleshoot performance. This ensures precise control and diagnostics in a controlled clinical environment.

• Is the Omnicor Programmer Model 222A a single-use or reusable device, and what maintenance is required?

  The Omnicor Programmer Model 222A is a reusable medical instrument. Since it is intended for repeated use in clinical settings, it requires proper calibration and maintenance as outlined by the manufacturer to ensure accuracy, reliability, and compliance with regulatory standards.

• What regulatory pathway was followed for FDA clearance of the Omnicor Programmer Model 222A, and what classification does it hold?

  The Omnicor Programmer Model 222A was cleared through the FDA’s 510(k) pathway under a Traditional review process, classified as a Class III medical device. It was determined to be substantially equivalent to a predicate device and is governed by regulation number 870.3700, ensuring adherence to cardiovascular device standards.

• Which pacemaker models is the Omnicor Programmer Model 222A compatible with, and how are these models identified?

  The Omnicor Programmer Model 222A is compatible with a range of implantable pacemaker models, as indicated by the listed FEI numbers (e.g., 3011120183, 2017865, etc.) and registration numbers in the FDA database. These identifiers help clinicians confirm compatibility before use. The exact models are referenced in the manufacturer’s documentation.