De Novo · Granted
GrantedSonablate 450
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonacare Medical, LLC · PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Granted on Oct 9, 2015 as a new device type through De Novo after a 200-day review. 8 later devices descend from it.
- Decided
- Oct 9, 2015
- Review
- 200 days
- Class
- Class II
- Product code
- PLP
- Recalls
- None
8 later devices descend from it, 1 citing it directly.
- This deviceDEN150011 Sonablate 450Sonacare Medical, LLC · 2015
- Descendant · cites it directly · 7 of its ownK153023 Ablatherm Integrated ImagingEdap Technomed, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK191200 TULSA-PRO SystemProfound Medical, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK172721 Focal OneEdap Technomed, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK251910 Focal One®Edap Technomed, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK230692 TULSA-PRO SystemProfound Medical, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153023Ablatherm Integrated ImagingEdap Technomed, Inc. · 2015 · cites it directly7descendants
- K191200TULSA-PRO SystemProfound Medical, Inc. · 2019 · 2 generations on3descendants
- K172721Focal OneEdap Technomed, Inc. · 2018 · 2 generations on1descendant
- K251910Focal One®Edap Technomed, Inc. · 2025 · 3 generations on0descendants
- K230692TULSA-PRO SystemProfound Medical, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150011 | Sonablate 450 | Sonacare Medical, LLC | 2015 | — |
| +1 | K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015 | 1 |
| +2 | K191200 | TULSA-PRO System | Profound Medical, Inc. | 2019 | — |
| +2 | K172721 | Focal One | Edap Technomed, Inc. | 2018 | — |
| +3 | K251910 | Focal One® | Edap Technomed, Inc. | 2025 | — |
| +3 | K230692 | TULSA-PRO System | Profound Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 K251910 Focal One®score 11.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153023 | Ablatherm Integrated Imaging | 2015 | 7 |
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?
- Of its descendants, K153023 (Edap Technomed, Inc., 2015) has gone furthest, with 7 descendants of its own.
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. 2015, 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?
transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150011 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN150011: Sonablate 450.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN150011
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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