# DEN180060: Plenity

- Pathway: De Novo (Direct)
- Applicant: Gelesis, Inc.
- Decided: Apr 12, 2019 after 148 days
- Product code: QFQ (Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss)
- Device class: 2
- Regulation: 21 CFR 876.5982
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K240544: Epitomee (2024), 0 descendants of its own
- K230133: Plenity (2024), 0 descendants of its own

## Indications for use
Plenity is indicated to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25 - 40 kg/m2, when used in conjunction with diet and exercise.

Source page: https://510kreport.com/device/DEN180060
Methodology: https://510kreport.com/methodology