Cleared Traditional

K243520 - Bullsai Confirm (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243520 · Turing Medical Technologies, Inc. · Neurology device
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Mar 2025
Decision
135d
Days
Class 2
Risk

K243520 is an FDA 510(k) clearance for the Bullsai Confirm. Classified as Brain Stimulation Programming Planning Software. (product code QQC), Class II - Special Controls.

Submitted by Turing Medical Technologies, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 28, 2025 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5855 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Turing Medical Technologies, Inc. devices

Submission Details

510(k) Number K243520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2024
Decision Date March 28, 2025
Days to Decision 135 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 148d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QQC Brain Stimulation Programming Planning Software.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5855
Definition The Brain Stimulation Programming Planning Software Is A Prescription Device Intended To Assist In Planning Stimulation Programming For Implanted Brain Stimulators.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.