Resuscitator
by American Medical Technology, Inc.
510(k) K874567
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874567 | Date29 Feb 1988 | 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- Withdrawn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
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an Emergency, Manual (Resuscitator) Ventilator, designed to provide manual ventilation support during resuscitation efforts. It delivers oxygen or air to a patient’s lungs when spontaneous breathing is absent or inadequate, ensuring oxygenation during critical interventions such as cardiopulmonary resuscitation (CPR). The device is classified as a Class II medical device under FDA regulations and is intended for use in emergency medical settings where immediate respiratory assistance is required.
The Resuscitator is supplied as a reusable device and is intended for use in clinical environments such as hospitals, emergency rooms, and pre-hospital settings. It is not sterile upon packaging and must be cleaned and disinfected between uses. The device is not MRI-compatible and is available in configurations compatible with standard oxygen tanks and face masks. Authorized under FDA 510(k) clearance (K874567), it adheres to regulatory standards for emergency respiratory support devices, ensuring compliance with safety and performance requirements.
Other devices from American Medical Technology, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the American Medical Resuscitator designed for?
The American Medical Resuscitator is an emergency manual ventilator intended to provide manual ventilation support during resuscitation efforts. It delivers oxygen or air to a patient’s lungs when spontaneous breathing is absent or inadequate, ensuring oxygenation during critical interventions such as cardiopulmonary resuscitation (CPR). This device is specifically designed for use in emergency medical settings, including hospitals, emergency rooms, and pre-hospital environments where immediate respiratory assistance is required.
Is the Resuscitator reusable or single-use?
The Resuscitator is a reusable device. It is intended for use in clinical environments and must be cleaned and disinfected between uses to maintain safety and hygiene standards. This design ensures it can be utilized repeatedly in emergency medical scenarios.
How is the Resuscitator supplied and what are its sterility requirements?
The Resuscitator is supplied as a reusable device and is not sterile upon packaging. It must be cleaned and disinfected between each use to prevent contamination and ensure proper functionality. This process is critical for maintaining the device’s performance and safety in clinical settings.
What configurations and accessories does the Resuscitator support?
The Resuscitator is compatible with standard oxygen tanks and face masks, making it versatile for use in various emergency medical scenarios. Its design ensures it can be easily integrated into existing respiratory support systems in hospitals, emergency rooms, and pre-hospital settings.
How should the Resuscitator be stored?
Since the Resuscitator is reusable and requires cleaning and disinfection between uses, it should be stored in a clean, dry environment when not in use. Proper storage helps maintain the device’s integrity and ensures it is ready for immediate use during emergencies. Follow manufacturer guidelines for storage to avoid damage or contamination.