FDA product code · Gastroenterology and urology
Prosthesis, Penile
32 FDA decisions since 1980. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K953640, named by 2 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 FAE 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 · FAE
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FAE
Too few FAE 510(k)s in any year since 2007 to give a median.
Recalls per year · FAE
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAE
195in 2025
MAUDE reports naming product code FAE, 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 | — | 2 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 87 |
| 2012 | 0 | — | 0 | 97 |
| 2013 | 0 | — | 0 | 108 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 0 | — | 0 | 98 |
| 2016 | 0 | — | 0 | 104 |
| 2017 | 0 | — | 0 | 123 |
| 2018 | 0 | — | 0 | 127 |
| 2019 | 2 | — | 0 | 221 |
| 2020 | 0 | — | 0 | 163 |
| 2021 | 0 | — | 0 | 167 |
| 2022 | 0 | — | 0 | 168 |
| 2023 | 0 | — | 0 | 160 |
| 2024 | 0 | — | 0 | 187 |
| 2025 | 0 | — | 0 | 195 |
| 2026 | 0 | — | 0 | — |
Planning a device in FAE? 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 876.3630.