510(k) · Cleared
ClearedTULSA-PRO System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Profound Medical, Inc. · PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Cleared on Sep 6, 2022 as substantially equivalent to K191200 (Profound Medical, Inc., 2019) after a 447-day review. Its family tree reaches back 3 generations to 2015.
- Decided
- Sep 6, 2022
- Review
- 447 days
- Class
- Class II
- Product code
- PLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150011 (2015). No later device cites it as a predicate yet.
- Root · 3 generations backDEN150011 Sonablate 450Sonacare Medical, LLC · 2015
- 2 generations backK153023 Ablatherm Integrated ImagingEdap Technomed, Inc. · 2015 · Recalled
- 1 generation backK191200 TULSA-PRO SystemProfound Medical, Inc. · 2019
- This deviceK211858 TULSA-PRO SystemProfound Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
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 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? (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.
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 7 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K191200.
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. 2022, 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 TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211858: TULSA-PRO System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211858
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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