510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190353Substantially Equivalent

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

Residential Home Sleep Services, Battle Creek MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190353 is the FDA 510(k) clearance record for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac, a class II device, cleared for Residential Home Sleep Services on under FDA product code PLC (Sleep Appliances With Patient Monitoring). FDA's definition for product code PLC reads: "For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy". FDA records list one 510(k) clearance for Residential Home Sleep Services. As of , FDA records show no recalls naming K190353.

Clearance record

Decision date
Received
(420 days to decision)
Product code
PLC Sleep Appliances With Patient Monitoring
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Residential Home Sleep Services 4602 Beckley Rd., Battle Creek MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLC

Trailing 12 months
2 clearances under product code PLC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PLC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260