510(k) · Cleared
ClearedFocal One®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edap Technomed, Inc. · PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Cleared on Nov 19, 2025 as substantially equivalent to K172721 (Edap Technomed, Inc., 2018) after a 152-day review. Its family tree reaches back 3 generations to 2015.
- Decided
- Nov 19, 2025
- Review
- 152 days
- Class
- Class II
- Product code
- PLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150011 (2015). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN150011 | Sonablate 450 | Sonacare Medical, LLC | 2015 | — |
| −2 | K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015 | 1 |
| −1 | K172721 | Focal One | Edap Technomed, Inc. | 2018 | — |
| 0 (this device) | K251910 | Focal One® | Edap Technomed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLP device
- #1 K230692 TULSA-PRO Systemscore 6.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172721 | Focal OneSummary page 5…e tissue ablation Regulatory Class: II Regulation: 21 CFR 876.4340 Product Code: PLP Predicate Device(s): EDAP Technomed, Inc.’s Focal One® (K172721) Intended Use: The Focal One® device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All PLP devicesPLP High Intensity Ultrasound System For Prostate Tissue Ablation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Focal One® is indicated for transrectal high-intensity focused ultrasound (HIFU) ablation of prostate tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251910: Focal One®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251910
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026