# DEN210003: SureTune4 Software

- Pathway: De Novo (Direct)
- Applicant: Medtronic Neuromodulation
- Decided: Aug 23, 2021 after 201 days
- Product code: QQC (Brain Stimulation Programming Planning Software.)
- Device class: 2
- Regulation: 21 CFR 882.5855
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243520: Bullsai Confirm (2025), 0 descendants of its own
- K213930: Brainlab Elements Guide XT, Guide 3.0 (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN210003
Methodology: https://510kreport.com/methodology