510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040161Substantially Equivalent

Sona Pillow

Sleep Devices, Inc., Kissimmee FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K040161 is the FDA 510(k) clearance record for SONA PILLOW, a class II device, cleared for Sleep Devices, Inc. on under FDA product code MYB (Pillow, Cervical (For Mild Sleep Apnea)). FDA records list one 510(k) clearance for Sleep Devices, Inc. As of , FDA records show no recalls naming K040161.

Clearance record

Decision date
Received
(98 days to decision)
Product code
MYB Pillow, Cervical (For Mild Sleep Apnea)
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Sleep Devices, Inc. 720 W. Oak St., Kissimmee FL
510(k) summary
Statement
Third party review
No

Clearances, product code MYB

Trailing 12 months

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

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