510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K181219Substantially Equivalent

OptiPillows EPAP Mask

Cpapnea Medical Supply, Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181219 is the FDA 510(k) clearance record for OptiPillows EPAP Mask, a class I device, cleared for Cpapnea Medical Supply on under FDA product code LWF (Dilator, Nasal). FDA records list one 510(k) clearance for Cpapnea Medical Supply. As of , FDA records show no recalls naming K181219.

Clearance record

Decision date
Received
(88 days to decision)
Product code
LWF Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Cpapnea Medical Supply 10443 N Cave Creek Rd., Suite 110, Phoenix AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LWF

Trailing 12 months

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

FDA records show no clearances under product code LWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWF, 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