Humidifier, Respiratory, Mask (Direct Patient Interface)
The Respiratory Humidifier Mask for Direct Patient Interface (product code OBN) is an anesthesiology device designed to moderate blood pressure in hypertensive patients exposed to cold environments by warming inhaled air through a face mask, thereby attenuating the physiological increase in blood pressure associated with cold exposure. It is indicated for both medicated and non-medicated individuals with hypertension. This device is FDA Class 2 under regulation 868.5450 in the Anesthesiology specialty, requiring 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OBN
- Device Class
- FDA class 2
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070467 | HEALTH MASK | Apr 17, 2007 | Substantially Equivalent | Polar Wrap, LLC |