FDA product code · Gastroenterology and urology
Prosthesis, Penis, Inflatable
1 FDA decision since 1998. 17 recalls name this code, 0 of them Class I.
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of JCW 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 · JCW
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCW
Too few JCW 510(k)s in any year since 2007 to give a median.
Recalls per year · JCW
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCW
1,617in 2025
MAUDE reports naming product code JCW, 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 | — | 5 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 6 | — | 0 | 13 |
| 2011 | 3 | — | 0 | 4 |
| 2012 | 4 | — | 0 | 7 |
| 2013 | 3 | — | 0 | 3 |
| 2014 | 5 | — | 1 | 2 |
| 2015 | 7 | — | 0 | 3 |
| 2016 | 11 | — | 0 | 5 |
| 2017 | 19 | — | 0 | 3 |
| 2018 | 9 | — | 0 | 4 |
| 2019 | 20 | — | 0 | 5 |
| 2020 | 12 | — | 1 | 7 |
| 2021 | 5 | — | 0 | 26 |
| 2022 | 5 | — | 0 | 15 |
| 2023 | 7 | — | 0 | 6 |
| 2024 | 4 | — | 0 | 266 |
| 2025 | 5 | — | 7 | 1,617 |
| 2026 | 2 | — | 0 | — |
Planning a device in JCW? 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 876.3350.