# K243520: Bullsai Confirm

- Pathway: 510(k) (Traditional)
- Applicant: Turing Medical Technologies, Inc.
- Decided: Mar 28, 2025 after 135 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
Longest line of descent: 1 generation back to DEN210003 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210003: SureTune4 Software, Medtronic Neuromodulation (2021) Summary page 5.

## Indications for use
Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

Source page: https://510kreport.com/device/K243520
Methodology: https://510kreport.com/methodology