FDA product code · Gastroenterology and urology
Device, Impotence, Mechanical/Hydraulic
1 FDA decision since 2000. 3 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 FHW 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 · FHW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FHW
Too few FHW 510(k)s in any year since 2007 to give a median.
Recalls per year · FHW
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FHW
2,537in 2025
MAUDE reports naming product code FHW, 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 | 11 |
| 2008 | 6 | — | 0 | 16 |
| 2009 | 2 | — | 1 | 15 |
| 2010 | 4 | — | 0 | 14 |
| 2011 | 5 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 5 | — | 0 | 19 |
| 2014 | 5 | — | 0 | 27 |
| 2015 | 10 | — | 0 | 9 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 2 | — | 0 | 512 |
| 2018 | 2 | — | 0 | 1,677 |
| 2019 | 3 | — | 0 | 4,010 |
| 2020 | 4 | — | 1 | 3,561 |
| 2021 | 2 | — | 1 | 3,715 |
| 2022 | 3 | — | 0 | 3,202 |
| 2023 | 3 | — | 0 | 3,673 |
| 2024 | 3 | — | 0 | 4,076 |
| 2025 | 2 | — | 0 | 2,537 |
| 2026 | 4 | — | 0 | — |
Planning a device in FHW? 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.