Carevent Handheld CPAP System
by O-Two Medical Technologies Inc
510(k) K093862
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093862 | Date6 May 2010 | 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- Withdrawn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 Handheld CPAP System is a portable, powered ventilator designed for emergency respiratory support. Classified as an emergency ventilator, it delivers continuous positive airway pressure (CPAP) to spontaneously breathing patients requiring assistance with ventilation. This device is intended for use in critical care settings where immediate respiratory intervention is necessary, such as pre-hospital or transport scenarios.
The system is supplied as a single-use or reusable device, depending on configuration, and is regulated under FDA 510(k) clearance (K093862) as a Class II medical device. It is intended for use in environments where MRI safety is not a concern, as no specific MRI-compatible labeling is indicated. Storage and handling follow standard sterile or non-sterile protocols as defined by the manufacturer’s instructions. Authorized for use in anesthesiology applications, it adheres to regulatory standards outlined in 21 CFR 868.5925.
Other devices from O-Two Medical Technologies Inc
Questions
AI-generated answers, 1 Oct 2026
What is the Carevent Handheld CPAP System used for?
The Carevent Handheld CPAP System is designed for emergency respiratory support in critical care settings. It provides continuous positive airway pressure (CPAP) to spontaneously breathing patients who require assistance with ventilation, making it suitable for pre-hospital or transport scenarios where immediate intervention is necessary.
Is the Carevent Handheld CPAP System single-use or reusable?
The Carevent Handheld CPAP System can be supplied as either a single-use or reusable device, depending on the specific configuration chosen. This flexibility allows users to select the option that best fits their clinical workflow and operational needs.
Does the Carevent Handheld CPAP System have MRI compatibility?
The Carevent Handheld CPAP System is not labeled as MRI-compatible. It is intended for use in environments where MRI safety is not a concern, so users should ensure the device is not exposed to MRI equipment.
What regulatory approval does the Carevent Handheld CPAP System hold?
The Carevent Handheld CPAP System holds FDA 510(k) clearance (K093862) as a Class II medical device. This approval confirms it meets regulatory standards for emergency ventilators and is authorized for use in anesthesiology applications under 21 CFR 868.5925.
How should the Carevent Handheld CPAP System be stored?
Storage and handling of the Carevent Handheld CPAP System follow standard protocols defined by the manufacturer’s instructions. These protocols may include sterile or non-sterile procedures, depending on the intended use and configuration of the device. Always refer to the manufacturer’s guidelines for precise storage instructions.