PMA · Approved
Recalled · Class II · 2025Brio Neurostimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Approved on Jun 12, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 403-day review. It has been recalled 5 times.
- Decided
- Jun 12, 2015
- Review
- 403 days
- Class
- Class III
- Product code
- MHY
- Recalls
- 5
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P140009 has 135 supplements since 2015: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2015 | 7 |
| 2016 | 12 |
| 2017 | 10 |
| 2018 | 10 |
| 2019 | 9 |
| 2020 | 11 |
| 2021 | 13 |
| 2022 | 6 |
| 2023 | 8 |
| 2024 | 23 |
| 2025 | 15 |
| 2026 | 11 |
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 MHY? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2025 | Class II | Z-0459-2026 | Process control | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may… |
| Jun 2, 2017 | Class II | Z-2694-2017 | Device Design | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. |
| Jun 2, 2017 | Class II | Z-2696-2017 | Device Design | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. |
| Jun 2, 2017 | Class II | Z-2695-2017 | Device Design | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. |
| Jun 2, 2017 | Class II | Z-2693-2017 | Device Design | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MHY devicesMHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MHY
44in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHY
Too few MHY 510(k)s in any year since 2007 to give a median.
Recalls per year · MHY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHY
3,373in 2025
MAUDE reports naming product code MHY, 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 | 3 | — | 3 | 710 |
| 2008 | 7 | — | 4 | 1,450 |
| 2009 | 18 | — | 0 | 1,314 |
| 2010 | 28 | — | 0 | 1,532 |
| 2011 | 31 | — | 0 | 1,597 |
| 2012 | 25 | — | 2 | 2,382 |
| 2013 | 23 | — | 1 | 2,845 |
| 2014 | 25 | — | 0 | 2,621 |
| 2015 | 18 | — | 0 | 3,088 |
| 2016 | 37 | — | 1 | 3,559 |
| 2017 | 45 | — | 1 | 3,561 |
| 2018 | 36 | — | 1 | 4,494 |
| 2019 | 42 | — | 0 | 2,817 |
| 2020 | 37 | — | 1 | 2,673 |
| 2021 | 36 | — | 3 | 2,427 |
| 2022 | 34 | — | 1 | 2,257 |
| 2023 | 31 | — | 1 | 3,489 |
| 2024 | 47 | — | 1 | 4,386 |
| 2025 | 44 | — | 1 | 3,373 |
| 2026 | 29 | — | 2 | — |
https://510kreport.com/device/P140009 · printed Nov 5, 2026
Cite this page
510(k) Report. “P140009: Brio Neurostimulation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P140009
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026