FDA product code · General and plastic surgery
Holder, Camera, Surgical
FDA lists FXR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1981. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FXR 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 · FXR
FDA has decided no FXR device since 2007.
Median 510(k) review, days · FXR
Too few FXR 510(k)s in any year since 2007 to give a median.
Recalls per year · FXR
No recall names FXR since 2007.
Adverse event reports per year · FXR
4in 2025
MAUDE reports naming product code FXR, 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 | 1 |
| 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 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 43 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
Planning a device in FXR? 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 878.4160.