King of Hearts CDM
510(k) K896040
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896040 | Date15 May 1990 | 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- Withdrawn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, 20 Sep 2026
The King of Hearts CDM is a Transmitter and Receiver, Electrocardiograph, Telephone, designed for remote monitoring of cardiac signals. It facilitates the transmission of electrocardiogram (ECG) data over telephone lines, enabling real-time or delayed cardiac assessment in clinical or home settings.
This device is supplied as a reusable medical instrument, intended for use in cardiovascular monitoring environments. It operates within standard MRI safety guidelines for non-MRI environments and requires no specific sterility measures beyond standard cleaning protocols. Authorized under FDA 510(k) clearance (K896040), it adheres to regulatory standards for Class II devices under the classification DXH, with no third-party involvement in distribution.
Other devices from Instromedix, Inc.
Questions
AI-generated answers, 20 Sep 2026
Is the King of Hearts CDM designed for single-use or can it be reused in a clinical setting?
The King of Hearts CDM is a reusable medical device, intended for use in cardiovascular monitoring environments. Since it is not classified as single-use, standard cleaning protocols are required to maintain its functionality and safety between uses. No specific sterility measures beyond routine cleaning are mentioned in the device description.
How is the King of Hearts CDM regulated, and what is its classification?
The King of Hearts CDM is classified as a Class II medical device under the FDA’s product code DXH (Transmitters and Receivers, Electrocardiograph, Telephone). It received FDA 510(k) clearance (K896040) in 1990, demonstrating it was determined to be substantially equivalent to a legally marketed device at the time. The device is not distributed through a third-party distributor, as indicated by the third_party_flag: N.
Can this device be used in environments where MRI machines are present, and what safety guidelines apply?
The King of Hearts CDM is designed for use in non-MRI environments and adheres to standard MRI safety guidelines for non-magnetic areas. Since it is not explicitly labeled as MRI-compatible, it should not be used in direct proximity to MRI machines or areas with strong magnetic fields. Always follow facility-specific safety protocols when deploying medical devices near MRI systems.
What types of cardiac monitoring does the King of Hearts CDM support, and how does it transmit data?
The King of Hearts CDM is an electrocardiograph transmitter and receiver that enables remote monitoring of cardiac signals. It transmits ECG data over telephone lines, allowing for real-time or delayed cardiac assessment in both clinical and home settings. This design is particularly useful for continuous or periodic monitoring of patients with cardiovascular conditions.
Are there multiple models or sizes available for the King of Hearts CDM, or is it a single-unit device?
The provided data does not specify distinct models or sizes for the King of Hearts CDM, but it references multiple FEI numbers (e.g., 3013689228, 3011265784), which may correspond to variations in the device’s configuration or accessories. However, no explicit details on differing unit sizes or configurations are included in the description. For precise model variations, consult the manufacturer’s documentation or support.