Carevent CA and DRA
by O-Two Medical Technologies Inc
510(k) K051889
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051889 | Date30 Aug 2005 | 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- Withdrawn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
- 510(k) Number
- FDA product code
- BTL
- FDA applicant
- O-Two Medical Technologies, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5925
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Carevent CA and DRA is an emergency powered resuscitator (ventilator) designed for use in hazardous chemical agent environments. It provides automatic ventilation with minimal rescuer intervention, ensuring rapid and effective patient resuscitation in life-threatening situations. This device is classified as a Class II medical device and is intended for use in scenarios requiring immediate respiratory support under hazardous conditions.
Supplied as a reusable medical device, the Carevent CA and DRA is intended for use in emergency settings where chemical agents or immediately dangerous to life and health (IDLH) environments are present. It requires connection to an oxygen/air supply and features a single external control for operation. The device has received FDA 510(k) clearance under Special Review with a classification under regulation number 868.5925, and is regulated under the Anesthesiology advisory committee category. No third-party review was required.
Other devices from O-Two Medical Technologies Inc
Questions
AI-generated answers, 1 Oct 2026
What is the Carevent CA and DRA designed for?
The Carevent CA and DRA is an emergency powered resuscitator specifically designed for use in hazardous chemical agent environments, where immediate respiratory support is critical. It provides automatic ventilation with minimal rescuer intervention, ensuring rapid and effective patient resuscitation in life-threatening situations involving chemical agents or immediately dangerous to life and health (IDLH) conditions.
Is the Carevent CA and DRA a single-use or reusable device?
The Carevent CA and DRA is supplied as a reusable medical device. This classification allows for repeated use in emergency settings, provided proper maintenance and cleaning protocols are followed to ensure safety and functionality.
What power source or supply does the Carevent CA and DRA require?
The Carevent CA and DRA requires connection to an external oxygen/air supply to operate. This ensures reliable ventilation support in hazardous environments where other power sources may be unreliable or unavailable.
How is the Carevent CA and DRA controlled during use?
The device features a single external control for operation, simplifying its use in emergency scenarios. This design minimizes rescuer fatigue and reduces the risk of errors during critical resuscitation efforts.
What regulatory pathway was followed for the Carevent CA and DRA?
The Carevent CA and DRA received FDA 510(k) clearance under Special Review, classified under regulation number 868.5925 and regulated under the Anesthesiology advisory committee category. No third-party review was required for this clearance.