Cleared Traditional

K242525 - iTOF

K242525 is an FDA 510(k) clearance for iTOF, manufactured by Nerbio Medical Software Platforms, Inc.. The device is a Class 2 Anesthesiology device with product code KOI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K242525 · Nerbio Medical Software Platforms, Inc. · Anesthesiology device
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Dec 2024
Decision
101d
Days
Class 2
Risk

K242525 is an FDA 510(k) clearance for the iTOF®. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Nerbio Medical Software Platforms, Inc. (San Jose, US). The FDA issued a Cleared decision on December 5, 2024 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nerbio Medical Software Platforms, Inc. devices

FDA 510(k) Submission Details - K242525

510(k) Number K242525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2024
Decision Date December 05, 2024
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 140d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KOI Device Classification - Class 2, Special Controls

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - KOI Stimulator, Nerve, Peripheral, Electric

All 22
Devices cleared under the same product code (KOI) and FDA review panel - the closest regulatory comparables to K242525.
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