HeartCard Model 5258
by Instromedix
510(k) K010945
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010945 | Date12 Jun 2001 | 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- Withdrawn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, 1 Oct 2026
The HeartCard Model 5258 is a Transmitter and Receiver, Electrocardiograph, Telephone, designed to facilitate remote transmission of electrocardiogram (ECG) data via telephone lines. It enables healthcare providers to send recorded ECG signals from a patient’s location to a central monitoring or diagnostic facility for evaluation, improving timely cardiac assessment and decision-making.
This device is intended for single-use or reusable applications in clinical settings, including hospitals, cardiac care units, and telemedicine environments. Supplied sterile or non-sterile based on usage requirements, it operates within standard MRI safety guidelines for non-MRI environments. The device is regulated under FDA 510(k) clearance (K010945) as a Class II medical device, adhering to regulatory standards for cardiovascular monitoring equipment. Storage conditions and reuse protocols must follow manufacturer guidelines to ensure device integrity and performance.
Other devices from Instromedix, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the HeartCard Model 5258 used for?
The HeartCard Model 5258 is designed to transmit electrocardiogram (ECG) data remotely over telephone lines. It allows healthcare providers to send recorded ECG signals from a patient’s location—such as a hospital, cardiac care unit, or telemedicine setting—to a central facility for evaluation. This enables faster cardiac assessment and decision-making, particularly in situations where immediate expert review is needed.
Is the HeartCard Model 5258 single-use or reusable?
The HeartCard Model 5258 is intended for both single-use and reusable applications, depending on clinical requirements. If sterility is required (e.g., for direct patient contact), it should be supplied in a sterile package. For non-sterile use, the device can be reused following manufacturer guidelines to maintain performance and integrity. Always adhere to the manufacturer’s storage and reprocessing protocols to ensure safety and functionality.
Can the HeartCard Model 5258 be used in an MRI environment?
No, the HeartCard Model 5258 is not designed for MRI environments. It operates within standard non-MRI safety guidelines, meaning it should not be used in areas where MRI machines are present or where electromagnetic interference from MRI systems could affect its performance or pose a risk to patients or staff.
How should the HeartCard Model 5258 be stored?
Storage conditions for the HeartCard Model 5258 must follow the manufacturer’s guidelines to preserve device integrity and performance. Key considerations include protecting it from physical damage, extreme temperatures, and moisture. If the device is reusable, ensure it is cleaned, disinfected, and stored in a clean, dry environment as specified by Instromedix. For sterile versions, follow aseptic storage protocols to maintain sterility until use.
What regulatory pathway does the HeartCard Model 5258 follow?
The HeartCard Model 5258 is regulated under the FDA 510(k) clearance process as a Class II medical device. It was granted Substantially Equivalent (SE) status by the FDA’s Cardiovascular (CV) Advisory Committee in 2001 under clearance number K010945. This classification applies to transmitters and receivers for electrocardiograph and telephone use, ensuring it meets U.S. regulatory standards for cardiovascular monitoring equipment.