Cardiodyne Kinetorr/PC Blood Pressure Monitors
510(k) K911871
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911871 | Date7 Nov 1991 | 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- Withdrawn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
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cardiodyne Kinetorr/PC Blood Pressure Monitors is a noninvasive blood pressure measurement system. It uses transducers placed on the surface of the body to derive and display systolic, diastolic, and mean arterial pressure readings. Designed for clinical use, this device provides accurate and reliable blood pressure measurements without invasive procedures. It falls under the category of cardiovascular monitoring equipment, specifically for noninvasive pressure assessment.
This device is intended for use in clinical settings such as hospitals, physician offices, and emergency care environments. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accuracy. The Cardiodyne Kinetorr/PC holds FDA 510(k) clearance under K911871, classified as a Class II device, and was determined to be substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the available data.
Other devices from Cardiodyne, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Cardiodyne Kinetorr/PC Blood Pressure Monitor used for?
The Cardiodyne Kinetorr/PC Blood Pressure Monitor is designed for noninvasive measurement of blood pressure in clinical settings. It uses transducers placed on the body surface to derive and display systolic, diastolic, and mean arterial pressure readings. This makes it suitable for environments like hospitals, physician offices, and emergency care, where continuous or periodic blood pressure assessment is required without invasive procedures.
Is the Cardiodyne Kinetorr/PC Blood Pressure Monitor reusable or single-use?
The Cardiodyne Kinetorr/PC Blood Pressure Monitor is supplied as a reusable medical instrument. Since it is intended for repeated use across multiple patients, proper calibration and maintenance are essential to ensure consistent accuracy and reliability over time.
Does the Cardiodyne Kinetorr/PC Blood Pressure Monitor require any special handling for sterility?
The available data does not specify any particular sterility requirements for the Cardiodyne Kinetorr/PC Blood Pressure Monitor. However, as a reusable device used in clinical settings, it should be cleaned and maintained according to standard infection control protocols to prevent cross-contamination between patients.
What regulatory clearance does the Cardiodyne Kinetorr/PC Blood Pressure Monitor hold?
The Cardiodyne Kinetorr/PC Blood Pressure Monitor holds FDA 510(k) clearance under the reference number K911871. It was classified as a Class II device and determined to be substantially equivalent to a predicate device, meaning it meets regulatory standards for safety and effectiveness as established by the FDA.
Where can the Cardiodyne Kinetorr/PC Blood Pressure Monitor be used?
This device is intended for use in clinical environments such as hospitals, physician offices, and emergency care settings. Its design supports accurate blood pressure monitoring in these controlled environments where noninvasive assessment is required for patient care.