Cleared Traditional

K252842 - SafeOp 3: Neural Informatix System

K252842 is an FDA 510(k) clearance for SafeOp 3: Neural Informatix System, manufactured by Alphatec Spine, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K252842 · Alphatec Spine, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
125d
Days
Class 2
Risk

K252842 is an FDA 510(k) clearance for the SafeOp 3: Neural Informatix System. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 11, 2026 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K252842

510(k) Number K252842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2025
Decision Date January 11, 2026
Days to Decision 125 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 148d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 94
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K252842.
BraiN20® (BraiN20)
K253301 · Time IS Brain, S.L. · Jun 2026
Nicolet EDX
K243982 · Natus Neurology Incorporated · Jan 2025
Natus Ultrapro S100 (982A0594)
K243495 · Natus Neurology Incorporated · Dec 2024
Delphi Stimulator
K242345 · Quantalx Neuroscience · Nov 2024
SafeOp 3: Neural Informatix Systeem
K234092 · Alphatec Spine, Inc. · Apr 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · Soterix Medical, Inc. · Mar 2024