510(k) · Cleared
ClearedPlenity
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
Cleared on Jan 19, 2024 as substantially equivalent to DEN180060 (Gelesis, Inc., 2019) after a 367-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jan 19, 2024
- Review
- 367 days
- Class
- Class II
- Product code
- QFQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180060 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180060 PlenityGelesis, Inc. · 2019
- This deviceK230133 PlenityGelesis, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180060 | Plenity | Gelesis, Inc. | 2019 | — |
| 0 (this device) | K230133 | Plenity | Gelesis, Inc. | 2024 | — |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180060 | PlenitySummary page 5…ose of three (3) capsules. Plenity OTC pods are supplied in a monthly kit. Predicate Device The Plenity OTC device is identical to the currently cleared device Plenity (DEN180060) in terms of its technological characteristics and mechanism of action. Although this application proposes to switch from prescri… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN180060.
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. 2024, 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 adults with excess weight or obesity, with a Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230133: Plenity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230133
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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