FDA product code · General and plastic surgery
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
6 FDA decisions since 2006. 3 recalls name this code, 0 of them Class I.
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FTR 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 · FTR
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTR
Too few FTR 510(k)s in any year since 2007 to give a median.
Recalls per year · FTR
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTR
30,958in 2025
MAUDE reports naming product code FTR, 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 | 5 | — | 0 | 94 |
| 2008 | 7 | — | 0 | 106 |
| 2009 | 4 | — | 0 | 53 |
| 2010 | 2 | — | 0 | 59 |
| 2011 | 2 | — | 0 | 101 |
| 2012 | 7 | — | 0 | 102 |
| 2013 | 12 | — | 0 | 120 |
| 2014 | 19 | — | 0 | 140 |
| 2015 | 28 | — | 0 | 204 |
| 2016 | 20 | — | 0 | 290 |
| 2017 | 33 | — | 0 | 930 |
| 2018 | 11 | — | 0 | 2,644 |
| 2019 | 14 | — | 2 | 21,411 |
| 2020 | 10 | — | 0 | 24,298 |
| 2021 | 21 | — | 0 | 23,365 |
| 2022 | 8 | — | 0 | 30,817 |
| 2023 | 10 | — | 0 | 29,098 |
| 2024 | 20 | — | 0 | 30,287 |
| 2025 | 16 | — | 0 | 30,958 |
| 2026 | 15 | — | 0 | — |
Planning a device in FTR? 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