510(k) · Cleared
ClearedSonablate
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
Cleared on Dec 21, 2016 after a 260-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 21, 2016
- Review
- 260 days
- Class
- Class II
- Product code
- PLP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK160942 SonablateSonacare Medical, LLC · 2016
- Descendant · cites it directly · 1 of its ownK212150 Exablate Prostate SystemInsightec, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK172721 Focal OneEdap Technomed, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK251910 Focal One®Edap Technomed, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231378 Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS…Insightec, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK172285 Ablatherm FusionEdap Technomed, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K212150Exablate Prostate SystemInsightec, Inc. · 2021 · cites it directly1descendant
- K172721Focal OneEdap Technomed, Inc. · 2018 · cites it directly1descendant
- K251910Focal One®Edap Technomed, Inc. · 2025 · 2 generations on0descendants
- K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0Insightec, Ltd. · 2023 · 2 generations on0descendants
- K172285Ablatherm FusionEdap Technomed, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K160942 | Sonablate | Sonacare Medical, LLC | 2016 | — |
| +1 | K212150 | Exablate Prostate System | Insightec, Inc. | 2021 | — |
| +1 | K172721 | Focal One | Edap Technomed, Inc. | 2018 | — |
| +2 | K251910 | Focal One® | Edap Technomed, Inc. | 2025 | — |
| +2 | K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate… | Insightec, Ltd. | 2023 | — |
| +1 | K172285 | Ablatherm Fusion | Edap Technomed, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K212150 (Insightec, Inc., 2021) has gone furthest, with 1 descendant 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. 2016, 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 Sonablate® is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K160942 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160942: Sonablate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160942
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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