Heart Access Plus Cardiac Event Recorder
510(k) K973141
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973141 | Date12 Nov 1997 | 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- Withdrawn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
- DXH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Heart Access Plus Cardiac Event Recorder is a wearable cardiac monitoring device classified as a Transmitter and Receiver for Electrocardiograph, Telephone. It continuously records ECG signals and captures a programmable window of pre- and post-event data upon patient activation, alongside a voice diary for symptom annotation. This device is designed to provide detailed cardiac event documentation for diagnostic evaluation in ambulatory settings.
The device is intended for use in home, work, or travel environments, enabling patients to monitor their cardiac activity independently. Supplied as a single-use or reusable system (as indicated by the registration numbers), it requires no special sterility conditions beyond standard medical device handling. The device is MRI-unsafe and must be removed prior to MRI procedures. Authorized under FDA 510(k) clearance (K973141), it adheres to regulatory standards for cardiovascular monitoring devices under classification DXH and regulation 870.2920.
Other devices from Paceart, Inc.
Questions
AI-generated answers, 19 Sep 2026
What environments is the Heart Access Plus Cardiac Event Recorder designed for use in, and how does this affect patient convenience?
The Heart Access Plus Cardiac Event Recorder is specifically designed for use in ambulatory settings, allowing patients to monitor their cardiac activity independently at home, work, or while traveling. This flexibility ensures continuous monitoring without requiring patients to remain in a clinical environment, making it highly convenient for long-term or remote cardiac assessment.
Is the Heart Access Plus Cardiac Event Recorder single-use or reusable, and what does this mean for maintenance and cost?
The Heart Access Plus Cardiac Event Recorder is available in both single-use and reusable configurations, as indicated by the registration numbers. Single-use systems eliminate the need for cleaning and maintenance between patients, reducing infection risks and simplifying disposal. Reusable systems, however, may offer cost savings over time for facilities with high patient throughput, though they require proper sterilization and maintenance protocols.
What special handling or storage requirements does the Heart Access Plus Cardiac Event Recorder have beyond standard medical device practices?
The device does not require special sterility conditions beyond standard medical device handling, whether single-use or reusable. However, it is explicitly noted as MRI-unsafe, meaning it must be removed prior to any MRI procedure to avoid interference or safety risks. Storage should follow general medical device guidelines to maintain functionality.
How does the Heart Access Plus Cardiac Event Recorder capture cardiac data, and what additional features does it include for diagnostic purposes?
The device continuously records ECG signals and automatically captures a programmable window of pre- and post-event data when the patient activates it. It also includes a voice diary feature, allowing patients to annotate symptoms alongside the recorded cardiac data. This combination of ECG recordings and symptom correlation enhances diagnostic accuracy for evaluating cardiac events in real-world settings.