FDA product code · Gastroenterology and urology
High Intensity Ultrasound System For Prostate Tissue Ablation
13 FDA decisions since 2015. 510(k) reviews decided 2021–2025 took a median of 162 days (half between 141 and 186). 1 recall names this code; it is not Class I. The most-cited predicate is K191200, named by 3 later devices.
Prostate tissue ablation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PLP 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 · PLP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLP
Too few PLP 510(k)s in any year since 2007 to give a median.
Recalls per year · PLP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLP
2in 2025
MAUDE reports naming product code PLP, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 1 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
Planning a device in PLP? 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