FDA product code · Immunology
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
8 FDA decisions since 1986. 6 recalls name this code, 0 of them Class I. The most-cited predicate is P850048, named by 3 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 MTF 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 · MTF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MTF
Too few MTF 510(k)s in any year since 2007 to give a median.
Recalls per year · MTF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTF
65in 2025
MAUDE reports naming product code MTF, 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 | 1 |
| 2008 | 9 | — | 1 | 4 |
| 2009 | 7 | — | 0 | 3 |
| 2010 | 10 | — | 0 | 5 |
| 2011 | 26 | — | 0 | 10 |
| 2012 | 19 | — | 1 | 17 |
| 2013 | 16 | — | 0 | 89 |
| 2014 | 14 | — | 0 | 12 |
| 2015 | 8 | — | 1 | 17 |
| 2016 | 6 | — | 2 | 16 |
| 2017 | 12 | — | 0 | 39 |
| 2018 | 10 | — | 0 | 30 |
| 2019 | 8 | — | 0 | 21 |
| 2020 | 14 | — | 0 | 14 |
| 2021 | 6 | — | 0 | 46 |
| 2022 | 5 | — | 0 | 45 |
| 2023 | 10 | — | 0 | 29 |
| 2024 | 4 | — | 1 | 31 |
| 2025 | 8 | — | 0 | 65 |
| 2026 | 9 | — | 0 | — |
Planning a device in MTF? 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