510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070467Substantially Equivalent

Health Mask

Polar Wrap, LLC, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070467 is the FDA 510(k) clearance record for HEALTH MASK, a class II device, cleared for Polar Wrap, LLC on under FDA product code OBN (Humidifier, Respiratory, Mask (Direct Patient Interface)). FDA's definition for product code OBN reads: "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...". FDA records list one 510(k) clearance for Polar Wrap, LLC. As of , FDA records show no recalls naming K070467.

Clearance record

Decision date
Received
(60 days to decision)
Product code
OBN Humidifier, Respiratory, Mask (Direct Patient Interface)
Regulation
21 CFR 868.5450
Device class
Class II
Review panel
Anesthesiology
Applicant
Polar Wrap, LLC 3460 Pt.e Creek Ct. #102, Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBN

Trailing 12 months

FDA records hold no clearances under product code OBN in the trailing twelve months.

FDA records show no clearances under product code OBN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OBN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260