CERYX6, 611, Ceryx 3 311 & Ceryx 1 111
by Vitatron Medical BV 510(k)
Active
510(k) K844485
Overview
The Ceryx6, 611, Ceryx 3 311 & Ceryx 1 111 are pacemaker programmers designed for programming and interrogating implantable cardiac pacemakers. These devices facilitate diagnostic and therapeutic adjustments to pacemaker function, enabling clinicians to monitor patient status and modify pacing parameters as needed.
Supplied as a reusable medical device, these programmers are intended for use in clinical settings such as hospitals and cardiac care facilities. The Ceryx series operates under FDA 510(k) clearance (K844485) and adheres to regulatory classification as a Class III device (OpenFDA: device_class=3, regulation_number=870.3700). Storage and handling follow standard medical device protocols to ensure functionality and sterility where applicable.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844485 | Date19 Apr 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KRG
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vitatron Medical BV
Questions
What clinical settings are these pacemaker programmers designed for and how are they used?
The Ceryx6, 611, Ceryx 3 311, and Ceryx 1 111 are reusable pacemaker programmers intended exclusively for use in clinical environments like hospitals and cardiac care facilities. They enable clinicians to program and interrogate implantable cardiac pacemakers, allowing diagnostic assessments and therapeutic adjustments to pacing parameters. This ensures precise monitoring of patient status and real-time modifications to pacemaker function as needed.
Are these devices single-use or reusable, and what does that mean for maintenance and handling?
These programmers are reusable medical devices, meaning they are designed for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Since they are not sterile (as they are not intended for direct patient contact), their handling follows standard medical device protocols to preserve functionality and hygiene. Clinics must adhere to manufacturer guidelines for servicing and storage to ensure reliable performance.
What regulatory pathway was followed for FDA clearance, and what does that imply about the device’s classification?
The Ceryx series underwent a Traditional 510(k) pathway with FDA clearance under K844485, classified as a Class III device under regulation number 870.3700. This classification reflects that the device is intended for critical cardiac applications, requiring rigorous pre-market review to ensure safety and effectiveness. The substantially equivalent decision (SESE) indicates it meets the performance criteria of a predicate device already on the market.
How do I determine which model (Ceryx6, 611, Ceryx 3 311, or Ceryx 1 111) is right for my facility?
The question of model selection depends on your facility’s specific needs for pacing parameter adjustments and diagnostic capabilities, as all four models serve the same core function of programming and interrogating implantable pacemakers. The differences lie in their specific programming features and compatibility with certain pacemaker models, which are detailed in the manufacturer’s technical documentation. Contact Vitatron Medical BV for guidance on compatibility with your existing pacemaker inventory.