Telcor 2
by Burdick Corp. 510(k)
Active
510(k) K821755
Overview
The Telcor 2 is a cardiac monitor, classified as a cardiotachometer with rate alarm, designed to measure and display heart rate. It falls under the OpenFDA classification of Class 2 Cardiovascular devices (product code DRT) and is intended for use in cardiovascular monitoring applications. This device provides real-time heart rate monitoring, which is critical for assessing cardiac function in clinical settings.
The Telcor 2 is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K821755) through the Traditional pathway. It was granted Substantially Equivalent status by the FDA’s Cardiovascular (CV) Advisory Committee in 1982. The device is intended for use in hospital or clinical environments, where its reliability and accuracy are essential for patient care. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821755 | Date2 Jul 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Burdick Corp.
Questions
What is the Telcor 2 used for?
The Telcor 2 is a Class 2 cardiotachometer with rate alarm designed specifically for measuring and displaying heart rate in real-time. It is intended for cardiovascular monitoring applications, particularly in hospital or clinical environments where continuous assessment of cardiac function is critical. Its primary purpose is to provide accurate and reliable heart rate data to support patient care decisions.
Is the Telcor 2 a single-use or reusable device?
The Telcor 2 is a reusable medical device. Unlike single-use devices, it is intended for repeated use across multiple patients after proper cleaning, maintenance, and sterilization procedures. This design allows healthcare facilities to maintain consistent monitoring capabilities without the need for frequent replacements.
What regulatory pathway does the Telcor 2 follow?
The Telcor 2 was granted FDA clearance through the Traditional 510(k) pathway, with the clearance number K821755. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device. The FDA’s Cardiovascular (CV) Advisory Committee reviewed and approved it in 1982, confirming its safety and effectiveness for its intended use in cardiovascular monitoring.
Does the Telcor 2 require sterilization before use?
The available data does not specify any sterility requirements for the Telcor 2. However, as a reusable device, it should be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene. If the device comes into contact with bodily fluids or is used in sterile environments, additional sterilization procedures may be necessary, though these are not detailed in the provided information.
What are the key specifications or models associated with the Telcor 2?
The Telcor 2 is classified under OpenFDA’s product code DRT (Cardiotachometer with Rate Alarm) and is listed with multiple registration numbers, including 3008717264 and others. These identifiers are used for tracking and regulatory purposes but do not indicate variations in the device’s core functionality. The device is intended for general cardiovascular monitoring and does not appear to have multiple model variants based on the provided data.