Ceryx Pacemaker Models 114, 314 & 614 - 114
by Vitatron Medical BV 510(k)
Active
510(k) K854790
Overview
The Ceryx Pacemaker Models 114, 314 & 614 are implantable pulse-generator devices designed to regulate heart rhythm by delivering electrical impulses to the heart when necessary. These devices are classified as Class III medical devices under FDA regulations and are intended for patients requiring cardiac pacing to manage bradycardia or other conduction disorders.
These pacemakers are supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings. They are regulated under FDA 510(k) clearance (K854790) and fall under the medical specialty of cardiovascular devices. Models 114, 314, and 614 are identified by their respective reference codes and are intended for use in accordance with standard implantable pacemaker procedures, with no specific MRI safety labeling indicated in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854790 | Date28 Aug 1986 | 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- Withdrawn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
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vitatron Medical BV
Questions
Are these pacemakers reusable or intended for single-use only, and how does that affect their handling and storage requirements?
The Ceryx Pacemaker Models 114, 314, and 614 are explicitly designed for single-use implantation and are supplied sterile. This means they must remain unopened until use and cannot be reused after implantation, reducing the risk of infection or device failure. Sterility ensures safety for the patient, so storage should follow manufacturer guidelines to maintain integrity—typically in a clean, dry environment away from direct sunlight or extreme temperatures.
What distinguishes the three models (114, 314, and 614) from each other, and how might a clinician choose between them?
The models are differentiated by their reference codes (114, 314, 614), though the provided data does not specify technical differences like pacing modes, battery life, or lead compatibility. Selection would depend on clinical needs, such as pacing requirements (e.g., single-chamber vs. dual-chamber) and patient-specific factors like heart anatomy. Consult the manufacturer’s technical documentation or a device specialist to confirm compatibility with the patient’s condition and procedural setup.
How is the regulatory pathway for these pacemakers structured, and what does the FDA’s 510(k) clearance (K854790) imply about their safety and equivalence?
The Ceryx Pacemakers were cleared via the FDA’s 510(k) process, specifically under Traditional Review by the Cardiovascular (CV) Advisory Committee. The clearance (K854790) indicates these devices are substantially equivalent to legally marketed pacemakers already on the market, meaning they share similar intended use, design, and performance characteristics. This pathway ensures they meet FDA safety and effectiveness standards for managing bradycardia or conduction disorders, though specific clinical indications are not detailed beyond the general pacemaker purpose.
Can these pacemakers be used in patients who require MRI procedures, or are there any restrictions mentioned in the data?
The provided data does not include any MRI safety labeling for the Ceryx Pacemaker Models 114, 314, or 614. This implies there may be no explicit approval for MRI compatibility, and clinicians should exercise caution or follow strict MRI-safe protocols if imaging is required. Always verify with the manufacturer or consult MRI safety guidelines before proceeding, as pacemakers can pose risks during MRI procedures due to electromagnetic interference.