510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140190Substantially Equivalent

Night Shift

Advanced Brain Monitoring, Inc., Dousman WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140190 is the FDA 510(k) clearance record for NIGHT SHIFT, a class II device, cleared for Advanced Brain Monitoring, Inc. on under FDA product code MYB (Pillow, Cervical (For Mild Sleep Apnea)). FDA records list 15 510(k) clearances for Advanced Brain Monitoring, Inc., from to . As of , FDA records show no recalls naming K140190.

Clearance record

Decision date
Received
(125 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
Advanced Brain Monitoring, Inc. W324 S3649 County Rd. E, Dousman WI
510(k) summary
Summary PDF
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