De Novo · Granted
GrantedPlenity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gelesis, Inc. · QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Granted on Apr 12, 2019 as a new device type through De Novo after a 148-day review. 2 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 148 days
- Class
- Class II
- Product code
- QFQ
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180060 | Plenity | Gelesis, Inc. | 2019 | — |
| +1 | K240544 | Epitomee | Epitomee Medical, Ltd. | 2024 | — |
| +1 | K230133 | Plenity | Gelesis, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFQ device
- #1 K240544 Epitomeescore 8.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K240544 (Epitomee Medical, Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QFQ devicesQFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFQ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QFQ
Too few QFQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QFQ
No recall names QFQ since 2007.
Adverse event reports per year · QFQ
7in 2023
MAUDE reports naming product code QFQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180060 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180060: Plenity.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026