Suprima Model 254-22
by Intermedics, Inc. 510(k)
Active
510(k) K852339
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852339 | Date8 Nov 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 18 Sep 2026
The Suprema Model 254-22 is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart when necessary. It falls under the classification of a Class III medical device, requiring stringent regulatory oversight due to its critical role in managing life-threatening arrhythmias.
This device is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K852339) and adheres to the regulatory requirements outlined in 21 CFR 870.3610. The device is not MRI-safe, and proper handling, storage, and disposal procedures must be followed to ensure patient safety and compliance with medical device regulations.
Other devices from Intermedics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Suprema Model 254-22 pacemaker, and how does it function in the body?
The Suprema Model 254-22 is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering timed electrical impulses to the heart when it fails to beat properly. It is intended for patients experiencing life-threatening arrhythmias, ensuring consistent heart contractions to maintain proper circulation and cardiac function.
Is the Suprema Model 254-22 meant for single-use or can it be reused after implantation?
The device is supplied sterile and intended for single-use only. Once implanted, it is not designed for removal or reuse, as this would compromise patient safety and device efficacy.
How should the Suprema Model 254-22 be stored before implantation, and what precautions should be taken?
The device is sterile upon supply, so it must be stored in its original packaging to maintain sterility until use. Proper handling, including avoiding contamination or exposure to extreme temperatures, is critical. Additionally, since it is not MRI-safe, storage areas should be free from unnecessary electromagnetic interference.
What regulatory pathway does the Suprema Model 254-22 follow, and what does this mean for clinicians?
The device follows the FDA 510(k) clearance pathway (K852339), meaning it has been deemed substantially equivalent to a legally marketed predicate device. Clinicians can rely on its compliance with 21 CFR 870.3610, ensuring it meets stringent safety and performance standards for implantable pacemakers. This classification reflects its critical role in managing life-threatening arrhythmias.
Are there any special handling or disposal requirements for the Suprema Model 254-22?
Yes, due to its implantable nature and potential biohazard risks, the device must be disposed of according to medical waste regulations. Proper handling during and after use is essential to prevent contamination and ensure compliance with healthcare facility protocols. Additionally, since it is not MRI-safe, patients with this device should avoid MRI scans.