Microcor ECG Monitor
510(k) K851325
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851325 | Date21 May 1985 | 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- Withdrawn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
- DRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Microcor ECG Monitor is a Class II cardiac monitor designed for continuous electrocardiographic (ECG) monitoring. It records and displays the electrical activity of the heart, enabling clinicians to assess cardiac rhythm, detect arrhythmias, and monitor patients for signs of cardiac compromise. As classified under the FDA’s device type ‘Monitor, Cardiac (Including Cardiotachometer & Rate Alarm)’, it is intended for use in clinical settings where real-time cardiac assessment is critical.
This device is supplied as a reusable medical instrument, intended for use in hospital or clinical environments. It operates on alternating current (AC) power and is regulated under FDA 510(k) clearance (K851325) with a traditional review process. The monitor is not described as MRI-safe or single-use, and its regulatory status is limited to the stated FDA clearance. Multiple model variants are referenced in regulatory filings, though the core function remains consistent across versions.
Other devices from Microcor, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Microcor ECG Monitor used for?
The Microcor ECG Monitor is designed for continuous electrocardiographic (ECG) monitoring in clinical settings. It records and displays the heart’s electrical activity, allowing clinicians to assess cardiac rhythm, detect arrhythmias, and monitor patients for signs of cardiac compromise. This is particularly useful in environments where real-time cardiac assessment is critical, such as hospitals or intensive care units.
Is the Microcor ECG Monitor reusable or single-use?
The Microcor ECG Monitor is supplied as a reusable medical instrument. It is intended for repeated use in hospital or clinical environments, provided it is properly maintained and cleaned according to manufacturer guidelines. Reusability helps ensure consistent performance and cost-effectiveness in long-term clinical settings.
What regulatory approval does the Microcor ECG Monitor hold?
The Microcor ECG Monitor holds FDA 510(k) clearance under the classification ‘Monitor, Cardiac (Including Cardiotachometer & Rate Alarm).’ This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. The clearance number is K851325.
Does the Microcor ECG Monitor come in multiple models?
Yes, the Microcor ECG Monitor includes multiple model variants, as referenced in regulatory filings. While the core function of continuous ECG monitoring remains consistent across these models, specific features or specifications may vary. The device is classified under the FDA product code DRT, and the regulatory filings list numerous registration numbers, indicating a range of variants.
How is the Microcor ECG Monitor powered?
The Microcor ECG Monitor operates on alternating current (AC) power. This means it requires a standard electrical outlet for operation, making it suitable for use in clinical environments where AC power is readily available. No battery or additional power source is mentioned in the specifications.