510(k) · Cleared
ClearedEpitomee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epitomee Medical, Ltd. · QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Cleared on Sep 13, 2024 as substantially equivalent to DEN180060 (Gelesis, Inc., 2019) after a 199-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Sep 13, 2024
- Review
- 199 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 deviceK240544 EpitomeeEpitomee Medical, Ltd. · 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) | K240544 | Epitomee | Epitomee Medical, Ltd. | 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 K230133 Plenityscore 6.7 · 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…Ingested, transient, space occupying device for weight management and/or weight loss Product Code: QFQ Regulatory Class: II Predicate Device: Gelesis Inc.’s Plenity (DEN180060) Device Description The subject device of this 510(k) notification, Epitomee, is comprised of two components: The… | 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?
Epitomee 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/K240544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240544: Epitomee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240544
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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