Model 5650 Optimate Personal Programmer
510(k) K884522
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884522 | Date25 Aug 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 18 Sep 2026
The Model 5650 Optimate Personal Programmer is a Programmer, Pacemaker, classified as a Class III medical device under FDA regulations. This device is designed to program and configure implantable pacemakers, allowing clinicians to adjust pacing parameters, diagnostic settings, and patient-specific therapy profiles remotely or in-clinic. It interfaces with compatible pacemaker models to enable precise control over device functionality, ensuring optimal cardiac rhythm management for patients.
Supplied as a reusable clinical tool, the Model 5650 is intended for use in cardiac electrophysiology laboratories, outpatient clinics, and hospital settings. It operates under sterile or clean conditions when interfacing with implanted devices and requires proper calibration and maintenance per manufacturer guidelines. The device holds FDA 510(k) clearance (K884522) and adheres to regulatory standards outlined in 21 CFR 870.3700, ensuring compliance with cardiovascular device programming protocols. No MRI safety or single-use specifications are noted in the regulatory data.
Questions
AI-generated answers, 18 Sep 2026
What clinical settings is the Model 5650 Optimate Personal Programmer designed for use in, and how is it typically deployed during patient interactions?
The Model 5650 is intended for use in cardiac electrophysiology laboratories, outpatient clinics, and hospital settings where implantable pacemakers are programmed or adjusted. Since it interfaces directly with implanted devices, it must be used under sterile or clean conditions during patient interactions to maintain clinical standards. The device is a reusable clinical tool, requiring proper calibration and maintenance as specified by the manufacturer.
How does the Model 5650 ensure compatibility with different pacemaker models, and what types of adjustments can clinicians make with this device?
The Model 5650 is designed to interface with a range of compatible pacemaker models, as indicated by the associated FEI numbers (e.g., 3011120183, 3002807576, etc.). Clinicians can use it to program and configure pacing parameters, diagnostic settings, and patient-specific therapy profiles remotely or in-clinic. This allows for precise control over device functionality to optimize cardiac rhythm management.
Is the Model 5650 approved for use with MRI procedures, and what storage or handling requirements should be followed?
The regulatory data for the Model 5650 does not specify MRI safety features or restrictions, so its compatibility with MRI environments is not confirmed. As for storage, since it is a reusable clinical tool, it should be stored in a clean, dry environment per manufacturer guidelines to ensure proper functionality and longevity. No single-use or sterility specifications are noted beyond maintaining sterile conditions during patient interactions.
What regulatory pathway was followed for the FDA clearance of the Model 5650, and which advisory committee was involved in the review?
The Model 5650 received FDA clearance through a 510(k) submission (K884522) under the Traditional review pathway, determined to be *substantially equivalent* to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, as indicated by the advisory committee description and product code (KRG). Compliance with 21 CFR 870.3700 is also noted in the regulatory data.