# K070467: Health Mask

- Pathway: 510(k) (Traditional)
- Applicant: Polar Wrap, LLC
- Decided: Apr 17, 2007 after 60 days
- Product code: OBN (Humidifier, Respiratory, Mask (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000405 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020700: PMH 5000 Heated Humidifier for Respiratory Therapy, Pegasus Research Corp. (2004) Summary page 1.
- K020399: Resperate; Model RR-150, Intercure, Ltd. (2002) Summary page 1.

## Indications for use
The Health Mask is intended to moderate the expected physiological response to cold (i.e., increase in blood pressure). For diagnosed hypertensives 18 years or older.

Source page: https://510kreport.com/device/K070467
Methodology: https://510kreport.com/methodology