510(k) · Cleared
Recalled · Class II · 2017Ablatherm Integrated Imaging
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 6, 2015 as substantially equivalent to DEN150011 (Sonacare Medical, LLC, 2015) after a 22-day review. Its family tree reaches back 1 generation to 2015. 7 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2015
- Review
- 22 days
- Class
- Class II
- Product code
- PLP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150011 (2015). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN150011 Sonablate 450Sonacare Medical, LLC · 2015
- This deviceK153023 Ablatherm Integrated ImagingEdap Technomed, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK191200 TULSA-PRO SystemProfound Medical, Inc. · 2019
- 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 ownK230692 TULSA-PRO SystemProfound Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK211858 TULSA-PRO SystemProfound Medical, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191200TULSA-PRO SystemProfound Medical, Inc. · 2019 · cites it directly3descendants
- K172721Focal OneEdap Technomed, Inc. · 2018 · cites it directly1descendant
- K251910Focal One®Edap Technomed, Inc. · 2025 · 2 generations on0descendants
- K230692TULSA-PRO SystemProfound Medical, Inc. · 2023 · 2 generations on0descendants
- K211858TULSA-PRO SystemProfound Medical, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150011 | Sonablate 450 | Sonacare Medical, LLC | 2015 | — |
| 0 (this device) | K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015 | — |
| +1 | K191200 | TULSA-PRO System | Profound Medical, Inc. | 2019 | — |
| +1 | K172721 | Focal One | Edap Technomed, Inc. | 2018 | — |
| +2 | K251910 | Focal One® | Edap Technomed, Inc. | 2025 | — |
| +2 | K230692 | TULSA-PRO System | Profound Medical, Inc. | 2023 | — |
| +2 | K211858 | TULSA-PRO System | Profound Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | DEN150011 | Sonablate 450Summary page 4…em for prostate tissue ablation Regulatory Class: II Regulation: 21 CFR 876.4340 Product Code: PLP Predicate Device(s): Sonablate 450 (DEN150011) Device Description: The Ablatherm Integrated Imaging is a computer controlled medical device intended to provide High Inten… | 2015 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2017 | Class II | Z-0049-2018 | Other | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K191200 (Profound Medical, Inc., 2019) has gone furthest, with 3 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?
The Ablatherm® Integrated Imaging device is indicated for transrectal high intensity focused ultrasound (HIFU)
ablation of prostate tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153023: Ablatherm Integrated Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153023
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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