FDA product code OBN: Humidifier, Respiratory, Mask (Direct Patient Interface)
OBN is the FDA product code for humidifier, respiratory, mask (direct patient interface). It is a Class II device, regulated under 21 CFR 868.5450 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under OBN. The average 510(k) review took 60 days (median 60).
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.
Classification
| Field | Value |
|---|---|
| Device name | Humidifier, Respiratory, Mask (Direct Patient Interface) |
| Device class | Class II |
| Regulation | 21 CFR 868.5450 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OBN clearance
Top OBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polar Wrap, LLC | 1 | 2007-04-17 |
Most recent OBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070467 | Polar Wrap, LLC | HEALTH MASK | 2007-04-17 | 60 |
Recalls for OBN devices
openFDA lists no recalls for product code OBN.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0379 — Direct admission of patient for hospital observation care
Frequently asked questions
What is FDA product code OBN?
OBN is the FDA product code for humidifier, respiratory, mask (direct patient interface). It is a Class II device, regulated under 21 CFR 868.5450 and reviewed by the Anesthesiology panel.
What device class is OBN?
Class II, regulation 21 CFR 868.5450. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBN?
Across 1 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most OBN clearances?
Polar Wrap, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OBN
- Run a recall and safety report across every OBN manufacturer
- Watch product code OBN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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