Disposable Pressure Transducer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K841788 FDA 510(k)
- FDA Product Code
- DRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2850 FDA 510(k)
- Regulation Number
- 870.2850 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Blood-Pressure, Extravascular Transducer, classified as a Class II medical device. It is designed for single-use measurement of arterial and venous blood pressure in clinical settings. The transducer converts pressure signals into electrical outputs for accurate monitoring, ensuring reliable hemodynamic assessments during patient care.
The disposable transducer is intended for use in healthcare environments where sterility and patient safety are critical. Supplied as a sterile, single-use device, it requires no reprocessing and is compatible with standard monitoring systems. Authorized under FDA 510K clearance (K841788), it adheres to regulatory standards for cardiovascular applications. Storage follows manufacturer guidelines to maintain integrity until use.
Frequently asked questions
What is the Utah disposable pressure transducer used for?
The Utah disposable pressure transducer is designed for single-use measurement of arterial and venous blood pressure in clinical environments. It converts pressure signals into electrical outputs, enabling accurate hemodynamic monitoring during patient care. This makes it ideal for critical care, surgery, and other settings where precise blood pressure tracking is essential.
Is the Utah disposable pressure transducer sterile and single-use?
Yes, the Utah disposable pressure transducer is supplied as a sterile, single-use device. This ensures patient safety and eliminates the need for reprocessing, reducing the risk of contamination or cross-infection in healthcare settings.
How is the Utah disposable pressure transducer supplied, and what are its compatibility requirements?
The device is supplied as a sterile, pre-packaged unit ready for immediate clinical use. It is compatible with standard monitoring systems used for hemodynamic assessments, ensuring seamless integration into existing workflows.
Does the Utah disposable pressure transducer require any special storage conditions?
The transducer should be stored according to the manufacturer’s guidelines to maintain its integrity until use. Proper storage ensures the device remains sterile and functional, adhering to regulatory standards for medical devices.
What regulatory approval does the Utah disposable pressure transducer hold?
The Utah disposable pressure transducer is authorized under FDA 510K clearance (K841788), confirming its compliance with U.S. regulatory standards for cardiovascular applications. This clearance validates its safety and effectiveness for single-use blood pressure monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Disposable Pressure Transducers - Utah Medical OEM, Disposable Pressure Transducers - Utah Medical OEM, Blood Pressure Monitoring Products - Utah Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K841788 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA 510(k) K841788 24 fields · synced Oct 6, 2026