510(k) · Cleared
ClearedHealth Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polar Wrap, LLC · OBN Humidifier, Respiratory, Mask (Direct Patient Interface)
Cleared on Apr 17, 2007 as substantially equivalent to K020700 (Pegasus Research Corp., 2004) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Apr 17, 2007
- Review
- 60 days
- Class
- Class II
- Product code
- OBN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000405 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000405 | Intercure LTD. Respi-Low | Intercure, Ltd. | 2000 | — |
| −1 | K020399 | Resperate; Model RR-150 | Intercure, Ltd. | 2002 | — |
| 0 (this device) | K070467 | Health Mask | Polar Wrap, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OBN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020700 | PMH 5000 Heated Humidifier for Respiratory TherapySummary page 1…ory humidifier mask (direct patient interface) Device: Health Mask Predicate Devices: Pegasus - PMH500 Heated humidifier - K020700 RESPeRate - K020399 Device Description:, The Health mask is a device worn by an individual… | 2004 |
| * | K020399 | Resperate; Model RR-150Summary page 1…Health Mask Predicate Devices: Pegasus - PMH500 Heated humidifier - K020700 RESPeRate - K020399 Device Description:, The Health mask is a device worn by an individual outdoors when the air is cold. It is designed to retain… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K020700.
How does its category compare?
All OBN devicesOBN Humidifier, Respiratory, Mask (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OBN
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OBN
Too few OBN 510(k)s in any year since 2007 to give a median.
Recalls per year · OBN
No recall names OBN since 2007.
Adverse event reports per year · OBN
1in 2021
MAUDE reports naming product code OBN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070467: Health Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070467
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026