# K190353: Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

- Pathway: 510(k) (Traditional)
- Applicant: Residential Home Sleep Services
- Decided: Apr 10, 2020 after 420 days
- Product code: PLC (Sleep Appliances With Patient Monitoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K882303 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170692: Respire Pink Series with DentiTrac, Respire Medical Holding (2017) Summary page 4.
- K163580: ASD Oral Appliances, American Sleep Dentistry (2017) Summary page 4.

## Indications for use
The BFit Intraoral Appliances are likely to reduce snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older. Optionally, the DentiTrac Micro-Recorder may be incorporated into the Bfit device. The DentiTrac is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac System.

Source page: https://510kreport.com/device/K190353
Methodology: https://510kreport.com/methodology