# DEN150033: Sensor Monitored Alimentary Restriction Therapy (SMART) Device

- Pathway: De Novo (Direct)
- Applicant: Scientific Intake
- Decided: Sep 26, 2016 after 423 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K171165: SmartByte Device (2017), 0 descendants of its own

## Indications for use
The SMART 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/DEN150033
Methodology: https://510kreport.com/methodology