De Novo · Granted
GrantedSureTune4 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neuromodulation · QQC Brain Stimulation Programming Planning Software.
Granted on Aug 23, 2021 as a new device type through De Novo after a 201-day review. 2 later devices descend from it.
- Decided
- Aug 23, 2021
- Review
- 201 days
- Class
- Class II
- Product code
- QQC
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210003 | SureTune4 Software | Medtronic Neuromodulation | 2021 | — |
| +1 | K243520 | Bullsai Confirm | Turing Medical Technologies, Inc. | 2025 | — |
| +1 | K213930 | Brainlab Elements Guide XT, Guide 3.0 | Brainlab AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 QQC? 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 QQC device
- #1 K243520 Bullsai Confirmscore 9.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 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?
- Of its descendants, K243520 (Turing Medical Technologies, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QQC devicesQQC Brain Stimulation Programming Planning Software.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QQC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QQC
Too few QQC 510(k)s in any year since 2007 to give a median.
Recalls per year · QQC
No recall names QQC since 2007.
Adverse event reports per year · QQC
No MAUDE report names QQC since 2007.
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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210003 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210003: SureTune4 Software.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210003
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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