# DEN070014: Mandometer Iii

- Pathway: De Novo (Post-NSE)
- Applicant: Ab Mando
- Decided: Mar 31, 2011 after 1,380 days
- Product code: OBV (Eating Disorder Conditioning Tool)
- Device class: 2
- Regulation: 21 CFR 882.5060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Mandometer® device aids in the treatment of eating disorders. Mandometer® monitors a patient’s eating rate and provides feedback to the patient on learning normal eating behavior and normal feelings of satiety. Mandometer® requires use in conjunction with an established Mandometer treatment program.

Source page: https://510kreport.com/device/DEN070014
Methodology: https://510kreport.com/methodology