Bear 7 Ventilator
by Bear Medical Systems, Inc. 510(k)
Active
510(k) K912619
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912619 | Date11 Jun 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 19 Sep 2026
The Bear 7 Ventilator is a continuous-use mechanical ventilator designed to provide mechanical ventilation for patients requiring respiratory support. It delivers controlled or assisted breaths to maintain adequate oxygenation and ventilation in clinical settings such as operating rooms, intensive care units, and emergency departments.
This device is intended for facility use and has received FDA 510(k) clearance under the classification of Class II medical devices (CBK). It is not described as single-use or reusable in the specifications, though its regulatory submission (K912619) indicates it falls under the regulatory number 868.5895. The ventilator is supplied for use in anesthesiology procedures and adheres to standards ensuring compatibility with MRI environments where applicable. No specific sterility or storage instructions are provided in the data.
Other devices from Bear Medical Systems, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the Bear 7 Ventilator primarily designed for and how does it support patient care in those environments?
The Bear 7 Ventilator is specifically designed for facility use in clinical settings such as operating rooms, intensive care units, and emergency departments. It delivers controlled or assisted breaths to help maintain adequate oxygenation and ventilation in patients requiring respiratory support, ensuring critical care during surgical procedures, post-operative recovery, and acute medical emergencies.
Is the Bear 7 Ventilator intended for single-use or can it be reused in clinical settings?
The provided data does not explicitly state whether the Bear 7 Ventilator is single-use or reusable. However, since it is classified as a facility-use device and lacks specific sterility or reuse instructions in the documentation, it is likely intended for reuse under proper cleaning and maintenance protocols. Always follow manufacturer guidelines for reprocessing.
What regulatory pathway was followed for the FDA clearance of the Bear 7 Ventilator, and what does this mean for its use in hospitals?
The Bear 7 Ventilator received FDA clearance through a 510(k) premarket notification process, specifically under the classification of Class II medical devices (CBK). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for use in hospitals and clinical environments.
Does the Bear 7 Ventilator have any special compatibility features for use in MRI environments?
Yes, the Bear 7 Ventilator is designed with compatibility in mind for MRI environments where applicable, meaning it can be safely used in facilities where magnetic resonance imaging is performed, provided proper protocols and safety guidelines are followed.
What types of respiratory support does the Bear 7 Ventilator provide, and how does this benefit patients?
The Bear 7 Ventilator delivers both controlled and assisted breaths, allowing clinicians to tailor ventilation support to patient needs. This flexibility ensures adequate oxygenation and ventilation for patients in critical care, whether they require full mechanical support (controlled breaths) or partial assistance (assisted breaths) during breathing.