FDA product code · Gastroenterology and urology
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
4 FDA decisions since 2019. 510(k) reviews decided 2021–2025 took a median of 283 days (half between 241 and 325). No recall names this code. The most-cited predicate is DEN180060, named by 2 later devices.
This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QFQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in QFQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report