OPOMAT Manual Resuscitator Ventilator
by Euro-Am Pharma, Inc. 510(k)
Active
510(k) K912620
Overview
The OPOMAT Manual Resuscitator Ventilator is a manual emergency ventilator designed to provide respiratory support in critical situations. It falls under the classification of a ventilator, emergency, manual (resuscitator), and is intended for use with a face mask or airway tube to deliver controlled breaths to a patient. This device is typically employed during resuscitation efforts or when mechanical ventilation is unavailable or impractical.
The OPOMAT Manual Resuscitator Ventilator is supplied as a reusable device and is regulated under FDA 510(k) clearance (K912620) with a classification of Class II (BTM). It is intended for use in clinical settings such as emergency rooms, operating rooms, and pre-hospital environments. The device’s design adheres to regulatory standards outlined in 21 CFR 868.5915, ensuring compliance with safety and performance requirements for manual resuscitators. No specific sterility or MRI safety information is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912620 | Date4 Dec 1991 | 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- Withdrawn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
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Euro-Am Pharma, Inc.
Questions
Is the OPOMAT Manual Resuscitator Ventilator designed for single-use or can it be reused in clinical settings?
The OPOMAT Manual Resuscitator Ventilator is explicitly described as a reusable device, meaning it is intended for repeated use in clinical environments like emergency rooms, operating rooms, and pre-hospital settings. Since it is not labeled as single-use, proper cleaning and maintenance protocols must be followed to ensure safety and functionality between uses.
What types of environments is the OPOMAT Manual Resuscitator Ventilator intended for, and how does it differ from other manual resuscitators?
The OPOMAT is designed for emergency respiratory support in critical situations where mechanical ventilation is unavailable or impractical. It is specifically intended for use with a face mask or airway tube to deliver controlled breaths during resuscitation efforts. Unlike some manual resuscitators that may be disposable, this device is reusable and classified under FDA 510(k) clearance, making it suitable for repeated clinical use in settings like emergency rooms, operating rooms, and pre-hospital care.
Does the OPOMAT Manual Resuscitator Ventilator come with any specific sterility guarantees, and how should it be stored?
The provided data does not specify sterility requirements for the OPOMAT Manual Resuscitator Ventilator. Since it is a reusable device, proper cleaning and sterilization procedures must be followed between uses to maintain safety and compliance with clinical standards. Storage instructions are not detailed, but typical reusable medical devices should be kept in a clean, dry environment, protected from contamination, and away from direct sunlight or extreme temperatures.
What regulatory pathway was followed for the OPOMAT Manual Resuscitator Ventilator’s FDA clearance, and which advisory committee was involved?
The OPOMAT Manual Resuscitator Ventilator was cleared through the FDA 510(k) pathway, specifically under the classification of Class II (BTM). The device was reviewed by the Anesthesiology (AN) Advisory Committee and was determined to be substantially equivalent to a predicate device. The clearance number is K912620, and it adheres to regulatory standards outlined in 21 CFR 868.5915, ensuring compliance with safety and performance requirements for manual resuscitators.