FDA product code · General and plastic surgery
Prosthesis, Breast, Inflatable, Internal, Saline
3 FDA decisions since 2000. 6 recalls name this code, 0 of them Class I.
Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FWM 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 · FWM
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FWM
Too few FWM 510(k)s in any year since 2007 to give a median.
Recalls per year · FWM
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWM
8,724in 2025
MAUDE reports naming product code FWM, 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 | 3 | — | 0 | 307 |
| 2008 | 3 | — | 0 | 268 |
| 2009 | 3 | — | 0 | 123 |
| 2010 | 0 | — | 0 | 126 |
| 2011 | 0 | — | 0 | 99 |
| 2012 | 1 | — | 0 | 142 |
| 2013 | 7 | — | 0 | 105 |
| 2014 | 11 | — | 0 | 81 |
| 2015 | 6 | — | 0 | 110 |
| 2016 | 12 | — | 0 | 164 |
| 2017 | 14 | — | 0 | 4,487 |
| 2018 | 6 | — | 0 | 13,223 |
| 2019 | 5 | — | 1 | 15,465 |
| 2020 | 7 | — | 0 | 14,022 |
| 2021 | 9 | — | 1 | 11,350 |
| 2022 | 4 | — | 0 | 13,641 |
| 2023 | 6 | — | 0 | 10,640 |
| 2024 | 7 | — | 0 | 9,450 |
| 2025 | 6 | — | 0 | 8,724 |
| 2026 | 4 | — | 0 | — |
Planning a device in FWM? 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) Report