Draeger AV2 Anesthesia Ventilator
by Draeger Medical, Inc. 510(k)
Active
510(k) K802168
Overview
The Draeger AV2 Anesthesia Ventilator is a continuous-use ventilator designed for facility-based anesthesia applications. As classified under FDA’s device type Ventilator, Continuous, Facility Use, it provides mechanical ventilation support during surgical procedures, ensuring controlled delivery of oxygen and anesthetic gases to patients under anesthesia. The device is engineered to maintain precise respiratory parameters, including tidal volume, respiratory rate, and inspiratory-to-expiratory ratios, to support stable ventilation during anesthesia administration.
This ventilator is intended for use in operating rooms, recovery areas, and other clinical settings where anesthesia is administered. Supplied as a reusable medical device, it requires proper cleaning, disinfection, and maintenance in accordance with manufacturer guidelines to ensure sterility and functionality. The AV2 is classified as a Class II device under FDA regulations (regulation number 868.5895) and holds a FDA 510(k) clearance (K802168) with a decision date of December 20, 1980. It is not MRI-compatible and must be used in environments where electromagnetic interference is minimized. The device is supplied as part of a comprehensive anesthesia system and adheres to strict regulatory standards for safety and performance in critical care settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802168 | Date20 Dec 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Drager AV2 Anesthesia Ventilator
- 510(k) Number
- FDA Product Code
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Draeger Medical, Inc.
Questions
What is the Draeger AV2 Anesthesia Ventilator used for?
The Draeger AV2 Anesthesia Ventilator is designed specifically for facility-based anesthesia applications. It provides mechanical ventilation support during surgical procedures, ensuring controlled delivery of oxygen and anesthetic gases to patients under anesthesia. This includes use in operating rooms, recovery areas, and other clinical settings where anesthesia is administered.
Is the Draeger AV2 Anesthesia Ventilator reusable or single-use?
The Draeger AV2 Anesthesia Ventilator is a reusable medical device. To maintain its functionality and sterility, it requires proper cleaning, disinfection, and maintenance in accordance with the manufacturer’s guidelines. This ensures safe and reliable performance for repeated use in clinical settings.
What regulatory approval does the Draeger AV2 Anesthesia Ventilator hold?
The Draeger AV2 Anesthesia Ventilator holds FDA 510(k) clearance (K802168) and is classified as a Class II device under FDA regulations (regulation number 868.5895). This clearance confirms its substantial equivalence to a predicate device and compliance with safety and performance standards for continuous-use ventilators in facility settings.
Can the Draeger AV2 Anesthesia Ventilator be used in an MRI environment?
No, the Draeger AV2 Anesthesia Ventilator is not MRI-compatible. It must be used in environments where electromagnetic interference is minimized to avoid potential malfunctions or safety risks. Always verify the clinical setting’s compatibility with the device’s specifications.
What respiratory parameters does the Draeger AV2 Anesthesia Ventilator control?
The Draeger AV2 Anesthesia Ventilator is engineered to maintain precise respiratory parameters, including tidal volume, respiratory rate, and inspiratory-to-expiratory (I:E) ratios. These controls help ensure stable ventilation during anesthesia administration, supporting patient safety and procedural consistency.