# K171165: SmartByte Device

- Pathway: 510(k) (Special)
- Applicant: Scientific Intake
- Decided: May 18, 2017 after 28 days
- Product code: ONY (Oral Removable Retainer For Weight Management)
- Device class: 2
- Regulation: 21 CFR 876.5981
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150033 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150033: Sensor Monitored Alimentary Restriction Therapy (SMART) Device, Scientific Intake (2016) Summary page 4.

## Indications for use
The SmartByte device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range of 27-35 kg/m2 in conjunction with behavioral modification instruction.

Source page: https://510kreport.com/device/K171165
Methodology: https://510kreport.com/methodology