PMA · Approved
ApprovedExablate Model 4000 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insightec · POH Mr-Guided Focused Ultrasound System
Approved on Sep 16, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 181-day review.
- Decided
- Sep 16, 2026
- Review
- 181 days
- Class
- Class III
- Product code
- POH
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in POH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
How does its category compare?
All POH devicesPOH Mr-Guided Focused Ultrasound System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · POH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POH
Too few POH 510(k)s in any year since 2007 to give a median.
Recalls per year · POH
No recall names POH since 2007.
Adverse event reports per year · POH
41in 2025
MAUDE reports naming product code POH, 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 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 5 |
| 2018 | 4 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 33 |
| 2020 | 2 | — | 0 | 28 |
| 2021 | 2 | — | 0 | 35 |
| 2022 | 7 | — | 0 | 29 |
| 2023 | 7 | — | 0 | 29 |
| 2024 | 5 | — | 0 | 35 |
| 2025 | 5 | — | 0 | 41 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P150038/S044 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150038/S044: Exablate Model 4000 System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150038/S044
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Record history
- FDA decision record loaded Oct 30, 2026
- Page last updated Nov 3, 2026