FDA product code · Gastroenterology and urology
Dislodger, Stone, Basket, Ureteral, Metal
FDA lists FFL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 52 FDA decisions since 1979. 8 recalls name this code, 0 of them Class I. The most-cited predicate is K052048, named by 3 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FFL 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 · FFL
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FFL
Too few FFL 510(k)s in any year since 2007 to give a median.
Recalls per year · FFL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFL
496in 2025
MAUDE reports naming product code FFL, 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 | 68 |
| 2008 | 1 | — | 1 | 152 |
| 2009 | 0 | — | 0 | 194 |
| 2010 | 0 | — | 0 | 192 |
| 2011 | 1 | — | 0 | 129 |
| 2012 | 0 | — | 0 | 95 |
| 2013 | 0 | — | 0 | 98 |
| 2014 | 0 | — | 1 | 71 |
| 2015 | 0 | — | 0 | 79 |
| 2016 | 0 | — | 0 | 88 |
| 2017 | 1 | — | 0 | 517 |
| 2018 | 0 | — | 0 | 428 |
| 2019 | 1 | — | 0 | 351 |
| 2020 | 0 | — | 0 | 375 |
| 2021 | 0 | — | 0 | 358 |
| 2022 | 0 | — | 1 | 426 |
| 2023 | 0 | — | 0 | 593 |
| 2024 | 0 | — | 0 | 606 |
| 2025 | 0 | — | 0 | 496 |
| 2026 | 0 | — | 0 | — |
Planning a device in FFL? 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) ReportRelated product codes
Other codes under 21 CFR 876.4680.