Pace-Pulse/Computrac
by Bib, Inc.
510(k) K800782
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800782 | Date28 May 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3640
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Pace-Pulse/Computrac is an Analyzer, Pacemaker Generator Function, Indirect (per FDA classification KRE), designed to evaluate and analyze pacemaker function and performance. It assesses pacing parameters, including heart rate, output, and timing, to ensure proper operation of implanted pacemakers. This device aids clinicians in diagnosing and troubleshooting pacemaker-related arrhythmias or malfunctions by providing quantitative data on pacing activity.
Supplied as a reusable medical instrument, the Pace-Pulse/Computrac is intended for use in clinical settings such as hospitals and cardiac care units. It operates in conjunction with external pacemaker leads and is regulated under FDA 510(k) clearance (K800782) as a Class II device (regulation number 870.3640). No specific sterility or single-use requirements are noted in the regulatory submission, though standard infection control protocols should apply. The device’s functionality aligns with cardiovascular specialty applications, as classified by the FDA.
Other devices from Bib, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical scenarios is the Pace-Pulse/Computrac designed to assist with in a hospital setting?
The Pace-Pulse/Computrac is specifically designed to evaluate and analyze the function of implanted pacemakers, helping clinicians diagnose and troubleshoot arrhythmias or malfunctions. It measures key pacing parameters like heart rate, output, and timing to ensure the pacemaker is operating correctly. This makes it particularly useful in cardiac care units for assessing pacing activity and maintaining proper pacemaker performance.
Is the Pace-Pulse/Computrac a single-use or reusable device, and what infection control measures should be followed?
The Pace-Pulse/Computrac is a reusable medical instrument, as explicitly stated in its regulatory submission. While no specific sterility requirements are mentioned, standard infection control protocols must be followed to ensure safe reuse in clinical settings like hospitals and cardiac care units.
How is the Pace-Pulse/Computrac regulated, and what type of device classification does it fall under?
The Pace-Pulse/Computrac is regulated under the FDA’s 510(k) clearance process and is classified as a Class II device under regulation number 870.3640. It was granted substantial equivalence (SESE) in 1980 through a traditional review pathway, with its advisory committee classification being Cardiovascular (CV). The product code assigned is KRE, indicating its role as an indirect analyzer for pacemaker generator function.
What types of facilities or departments would benefit most from using the Pace-Pulse/Computrac?
The Pace-Pulse/Computrac is intended for use in clinical settings such as hospitals and cardiac care units, where implanted pacemakers are monitored and managed. Its functionality aligns with cardiovascular specialty applications, making it particularly valuable in electrophysiology labs, cardiac catheterization labs, or any department focused on pacemaker diagnostics and troubleshooting.