Alpha Non-Invasive Bp Cardule
510(k) K832764
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832764 | Date27 Jan 1984 | 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- Withdrawn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 Alpha Non-Invasive Blood Pressure Cardule is a non-invasive blood pressure measurement system designed for clinical use. Classified under the System, Measurement, Blood-pressure, Non-invasive nomenclature, it measures systolic and diastolic blood pressure via oscillometric technology, typically used in cardiovascular monitoring settings. Its primary function is to provide accurate, real-time blood pressure readings without invasive procedures, supporting diagnostic and patient management workflows.
This device is supplied as a reusable medical instrument, intended for use in clinical environments such as hospitals, physician offices, or ambulatory care settings. It is not sterile and requires proper cleaning and maintenance between uses. The device holds an FDA 510(k) clearance (K832764) under the Cardiovascular review panel, with a classification under regulation 870.1130. No additional sterility or MRI safety information is specified in the regulatory submission.
Other devices from Spacelabs, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Alpha Non-Invasive BP Cardule used for?
The Alpha Non-Invasive BP Cardule is designed for clinical blood pressure measurement using oscillometric technology. It provides real-time readings of systolic and diastolic pressure without invasive procedures, making it ideal for cardiovascular monitoring in settings like hospitals, physician offices, or ambulatory care. Its primary purpose is to assist in diagnostic evaluations and patient management by delivering reliable, non-invasive blood pressure data.
Is the Alpha Non-Invasive BP Cardule reusable or single-use?
The Alpha Non-Invasive BP Cardule is a reusable medical instrument. Since it is not sterile, it must be cleaned and maintained properly between uses to ensure accuracy and hygiene. This design allows for repeated use in clinical environments, reducing waste and operational costs.
Does the Alpha Non-Invasive BP Cardule require sterilization?
No, the Alpha Non-Invasive BP Cardule is not sterile and is not intended for sterile procedures. It is designed for clinical use where non-invasive, reusable devices are appropriate. Proper cleaning and maintenance between patient interactions are required to prevent contamination and ensure reliable performance.
Where can the Alpha Non-Invasive BP Cardule be used?
This device is intended for use in clinical environments such as hospitals, physician offices, and ambulatory care settings. Its oscillometric technology is well-suited for monitoring blood pressure in patients where invasive methods are unnecessary, supporting workflows in cardiovascular diagnostics and ongoing patient care.
What regulatory clearance does the Alpha Non-Invasive BP Cardule hold?
The Alpha Non-Invasive BP Cardule holds an FDA 510(k) clearance (K832764) under the Cardiovascular review panel. It is classified under regulation 870.1130 and is considered substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for non-invasive blood pressure measurement systems.