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 Aug 15, 2019 as substantially equivalent to K153023 (Edap Technomed, Inc., 2015) after a 101-day review. Its family tree reaches back 2 generations to 2015. 3 later devices descend from it.
- Decided
- Aug 15, 2019
- Review
- 101 days
- Class
- Class II
- Product code
- PLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150011 (2015). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backDEN150011 Sonablate 450Sonacare Medical, LLC · 2015
- 1 generation backK153023 Ablatherm Integrated ImagingEdap Technomed, Inc. · 2015 · Recalled
- This deviceK191200 TULSA-PRO SystemProfound Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK230692 TULSA-PRO SystemProfound Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK211858 TULSA-PRO SystemProfound Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK202286 Tulsa-Pro SystemProfound Medical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150011 | Sonablate 450 | Sonacare Medical, LLC | 2015 | — |
| −1 | K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015 | 1 |
| 0 (this device) | K191200 | TULSA-PRO System | Profound Medical, Inc. | 2019 | — |
| +1 | K230692 | TULSA-PRO System | Profound Medical, Inc. | 2023 | — |
| +1 | K211858 | TULSA-PRO System | Profound Medical, Inc. | 2022 | — |
| +1 | K202286 | Tulsa-Pro System | Profound Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153023 | Ablatherm Integrated ImagingSummary page 5…PRO System III. Predicate Device Information Predicate Device Ablatherm Integrated Imaging 510(k) Number K153023 Decision Date Nov 6, 2015 Manufacturer EDAP Technomed, Inc. IV… | 2015 |
What descends from it? (3)
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K230692 (Profound Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K153023.
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. 2019, 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 System is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191200 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191200: 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/K191200
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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