FDA product code · Gastroenterology and urology
Enema Kit
FDA lists FCE 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. 30 FDA decisions since 1976. No recall names this code.
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FCE 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 · FCE
FDA has decided no FCE device since 2007.
Median 510(k) review, days · FCE
Too few FCE 510(k)s in any year since 2007 to give a median.
Recalls per year · FCE
No recall names FCE since 2007.
Adverse event reports per year · FCE
2in 2025
MAUDE reports naming product code FCE, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
Planning a device in FCE? 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 876.5210.