PMA · Approved
ApprovedExablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insightec, Ltd. · NRZ Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
Approved on Jul 23, 2025 through premarket approval, which rests on the device’s own clinical evidence after a 28-day review.
- Decided
- Jul 23, 2025
- Review
- 28 days
- Class
- Class III
- Product code
- NRZ
- 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 NRZ? 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 NRZ devicesNRZ Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NRZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRZ
Too few NRZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NRZ
No recall names NRZ since 2007.
Adverse event reports per year · NRZ
2in 2025
MAUDE reports naming product code NRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 5 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 5 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 3 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P040003/S022 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040003/S022: Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040003/S022
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026