Omnicor Programmer Model 222C

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

510(k) Number

K791419 ↗

FDA product code

KRG

Device class

Class III

Regulation

21 CFR Part 870.3700

Advisory committee

Cardiovascular

FDA decision

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See all devices from Cordis US Corp. →

• What is the primary purpose of the Omnicor Programmer Model 222C in a clinical setting?

  The Omnicor Programmer Model 222C is designed specifically for programming, testing, and configuring implantable cardiac devices. It allows clinicians to adjust pacing parameters, retrieve diagnostic data, and verify device functionality—critical tasks for managing patients with pacemakers or similar implants in hospital or electrophysiology lab environments.

• Is the Omnicor Programmer Model 222C intended for single-use or reusable applications?

  The Omnicor Programmer Model 222C is explicitly supplied as a reusable medical instrument. It is built for repeated use in controlled clinical environments, such as hospital electrophysiology labs, rather than disposable applications.

• What storage conditions are required to maintain the functionality of the Omnicor Programmer Model 222C?

  The device must be stored in a controlled environment to preserve its functionality. While the exact specifications aren’t detailed, the mention of a ‘non-MRI environment’ implies it should be kept away from magnetic fields, and general best practices for reusable medical equipment—like cleanliness and proper handling—likely apply.

• How is the Omnicor Programmer Model 222C regulated, and what does that mean for its use?

  The Omnicor Programmer Model 222C holds an FDA 510(k) clearance under the Cardiovascular advisory committee, classified as a Class III device. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in programming and managing implantable cardiac devices, though it does not imply approval for any specific clinical indication beyond its described functions.