Divan Anesthesia Ventilator
by Draeger Medical, Inc. 510(k)
Active
510(k) K980208
Overview
The Divan Anesthesia Ventilator is a continuous-use, facility-based ventilator designed for mechanical respiratory support. Classified under product code CBK, it is intended for use in anesthesia settings to deliver controlled ventilation to patients during surgical procedures or critical care scenarios. Its primary function is to regulate and assist breathing by controlling airflow, oxygen concentration, and pressure to ensure adequate gas exchange and patient safety.
This device is supplied as a reusable medical instrument, intended for use within hospital or clinical environments. It requires proper maintenance, calibration, and sterilization procedures to ensure functionality and patient safety. The Divan Anesthesia Ventilator has received FDA 510(k) clearance under the Traditional review pathway, with a decision date of August 4, 1998, and is classified as a Class II device under special controls. It is regulated under FDA regulation number 868.5895 and is intended for facility use only.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980208 | Date4 Aug 1998 | 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- Withdrawn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
- 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 primary use case for the Divan Anesthesia Ventilator in clinical settings?
The Divan Anesthesia Ventilator is specifically designed for mechanical respiratory support during anesthesia, ensuring controlled ventilation for patients undergoing surgical procedures or critical care scenarios. It regulates airflow, oxygen concentration, and pressure to maintain safe and effective gas exchange, making it ideal for use in operating rooms or intensive care units where precise respiratory management is required.
Is the Divan Anesthesia Ventilator intended for single-use or reusable applications, and what maintenance is required?
The Divan Anesthesia Ventilator is not single-use—it is classified as a reusable medical instrument for facility-based use. To ensure functionality and patient safety, it requires proper maintenance, calibration, and sterilization as part of routine hospital or clinical protocols. Reusability is contingent on adherence to these procedures.
How is the regulatory status of this ventilator defined, and what does that mean for purchasing hospitals?
The Divan Anesthesia Ventilator holds FDA 510(k) clearance under the Traditional review pathway, granted on August 4, 1998, and is classified as a Class II device under special controls. This means it has been deemed substantially equivalent to a predicate device and meets FDA requirements for safety and effectiveness. Hospitals purchasing it can rely on this clearance as evidence of regulatory compliance for facility use.
What types of facilities or departments would benefit most from implementing this ventilator?
This ventilator is exclusively intended for facility-based use, making it most suitable for operating rooms, surgical suites, and intensive care units (ICUs) where anesthesia and critical care ventilation are provided. Its design aligns with the needs of anesthesiology departments, where precise respiratory support is critical during procedures.
Are there specific size or model variations available for the Divan Anesthesia Ventilator, or is it a single-unit device?
The provided data does not specify individual size or model variations for the Divan Anesthesia Ventilator, but it is listed under FDA registration numbers and product code CBK, which may correspond to multiple units or configurations. For exact specifications, such as flow rates, pressure limits, or connectivity options, refer to the manufacturer’s technical documentation or contact Draeger Medical directly.