Identifiers
- 510(k) Number
- K981072 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- ST FDA 510(k)
The Esprit Ventilator is a continuous-use, facility-based mechanical ventilator designed to provide respiratory support for patients. It delivers controlled or assisted ventilation through precise pressure and volume regulation, ensuring adequate oxygenation and ventilation in critical care settings.
This device is intended for use in hospital environments and is supplied as a reusable medical instrument. It adheres to MRI safety standards for facility use and is subject to FDA clearance under 510(k) regulations. The ventilator operates under strict regulatory oversight, including compliance with consensus guidelines and applicable safety requirements for life-support devices.
Frequently asked questions
Is the Esprit Ventilator designed for use outside of a hospital setting, or is it strictly for facility-based critical care environments?
The Esprit Ventilator is explicitly designed for facility-based use only, as stated in the description. It is intended for continuous respiratory support in hospital environments where critical care is provided, not for home use or portable settings.
How is the Esprit Ventilator supplied, and is it intended for single-use or reusable applications?
The Esprit Ventilator is supplied as a reusable medical instrument, meaning it is not designed for single-use. It requires proper cleaning, maintenance, and reprocessing between patient use, as outlined in its regulatory and operational documentation.
Does the Esprit Ventilator have any compatibility with MRI equipment, and if so, how does this affect its use in a hospital?
Yes, the Esprit Ventilator adheres to MRI safety standards for facility use, allowing it to be operated in hospital environments where MRI procedures are performed. This ensures compatibility with MRI-compatible monitoring and imaging systems, reducing risks during concurrent use.
What regulatory pathway was followed for the FDA clearance of the Esprit Ventilator, and what does this imply for its oversight?
The Esprit Ventilator received FDA clearance through a 510(k) submission, classified as *Substantially Equivalent* under *Traditional* clearance with *Anesthesiology* advisory committee involvement. This implies it is subject to ongoing regulatory tracking and compliance with life-support device safety standards, ensuring rigorous oversight for its use in critical care.
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: RESPIRONICS ESPRIT OPERATOR'S MANUAL Pdf Download, RESPIRONICS ESPRIT SERVICE MANUAL Pdf Download | ManualsLib, PDF ESPRIT® Ventilator, PDF ESPRIT Ventilator E - ia802909.us.archive.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981072 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K981072 24 fields · synced Sep 19, 2026