Disposable Pressure Transducer
by Advance Medical Designs, Inc.
510(k) K904601
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904601 | Date17 Dec 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- Withdrawn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
- Full name
- Advance Disposable Pressure Transducer
- 510(k) Number
- FDA Product Code
- DRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2850
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Disposable Pressure Transducer is a blood-pressure monitoring device designed for extravascular measurement. Classified as a Class II medical device under FDA regulations, it converts pressure signals into electrical outputs for accurate hemodynamic assessment, commonly used in cardiovascular settings to track intravascular or non-invasive pressure parameters in real-time.
This single-use device is intended for sterile use in clinical environments such as operating rooms, intensive care units, or cardiac catheterization labs. Supplied as a sterile, disposable unit, it requires no reprocessing and adheres to FDA 510(k) clearance (K904601) for cardiovascular applications. Compatibility with standard monitoring systems ensures seamless integration into existing workflows, with no MRI safety restrictions specified.
From the manufacturer
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Other devices from Advance Medical Designs, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical environments is the ADVANCE DISPOSABLE PRESSURE TRANSDUCER intended for use in?
The device is designed for sterile, single-use applications in high-precision cardiovascular settings such as operating rooms, intensive care units (ICUs), and cardiac catheterization labs. Its extravascular pressure measurement capabilities make it suitable for real-time hemodynamic assessment in patients where cardiovascular monitoring is critical.
How is the ADVANCE DISPOSABLE PRESSURE TRANSDUCER supplied, and is it reusable?
The device is supplied as a sterile, disposable unit, meaning it is intended for one-time use only and does not require reprocessing or sterilization between patients. This ensures patient safety and reduces the risk of contamination.
Can this device be used with existing monitoring systems, and are there any MRI safety restrictions?
Yes, the ADVANCE DISPOSABLE PRESSURE TRANSDUCER is designed to be compatible with standard monitoring systems, allowing seamless integration into current clinical workflows. However, there are no MRI safety restrictions specified for this device, though its use in MRI environments should still be evaluated based on facility protocols and manufacturer guidelines.
What regulatory pathway was followed for FDA clearance of the ADVANCE DISPOSABLE PRESSURE TRANSDUCER?
The device received FDA clearance through a 510(k) submission, classified as a Class II medical device under FDA regulations. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent (SESE) to a predicate device, with clearance granted on December 17, 1990 (K904601).
Is the device compatible with non-invasive or intravascular pressure monitoring?
While the device is specifically designed for extravascular pressure measurement, its hemodynamic assessment capabilities make it useful for tracking intravascular or non-invasive pressure parameters in real-time within cardiovascular settings. Its compatibility with standard monitoring systems ensures flexibility in clinical applications.