VHS 820 Humidifier
by Bear Medical Systems, Inc. 510(k)
Active
510(k) K893034
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893034 | Date14 Jul 1989 | 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- Withdrawn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
- Full name
- Vhs 820 Humidifier, Modification
- 510(k) Number
- FDA Product Code
- BTT
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5450
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The VHS 820 Humidifier is a Humidifier, Respiratory Gas, (Direct Patient Interface), designed to add moisture to inhaled gases during anesthesia or respiratory therapy. It ensures adequate hydration of respiratory gases to prevent airway irritation and maintain patient comfort during procedures requiring ventilatory support.
This device is intended for use in clinical settings such as operating rooms or anesthesia suites, where it connects to anesthesia machines or ventilators. Supplied as a reusable medical device, it requires proper cleaning, sterilization, and maintenance per manufacturer guidelines. The VHS 820 Humidifier is classified under FDA regulation 868.5450 and holds a FDA 510(k) clearance (K893034) under the Traditional 510(k) Review Process, with a Substantially Equivalent (SESE) determination by the Anesthesiology (AN) Advisory Committee.
Other devices from Bear Medical Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the VHS 820 Humidifier used for?
The VHS 820 Humidifier is designed to add moisture to respiratory gases during anesthesia or respiratory therapy. This helps prevent airway irritation and ensures patient comfort during procedures requiring ventilatory support, such as surgeries or critical care interventions.
Is the VHS 820 Humidifier reusable or single-use?
The VHS 820 Humidifier is a reusable medical device. After each use, it must be cleaned, sterilized, and maintained according to the manufacturer’s guidelines to ensure safety and functionality for subsequent procedures.
How is the VHS 820 Humidifier connected to anesthesia equipment?
The VHS 820 Humidifier is intended for use in clinical settings like operating rooms or anesthesia suites. It connects directly to anesthesia machines or ventilators to humidify inhaled gases, ensuring proper hydration and patient comfort during ventilatory support.
What maintenance is required for the VHS 820 Humidifier?
Since the VHS 820 is reusable, it requires thorough cleaning, sterilization, and regular maintenance as specified by Bear Medical Systems. Proper upkeep is essential to prevent contamination, ensure performance, and extend the device’s lifespan for repeated clinical use.
Where can the VHS 820 Humidifier be used?
This device is specifically intended for use in controlled clinical environments such as operating rooms, anesthesia suites, or respiratory therapy departments where ventilatory support is provided to patients.