Cleared Traditional

K231986 - Modus IR

K231986 is an FDA 510(k) clearance for Modus IR, manufactured by Synaptive Medical, Inc.. The device is a Class 2 Neurology device with product code IZI cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K231986 · Synaptive Medical, Inc. · Neurology device
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Mar 2024
Decision
264d
Days
Class 2
Risk

K231986 is an FDA 510(k) clearance for the Modus IR. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on March 25, 2024 after a review of 264 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 892.1600 - 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 Synaptive Medical, Inc. devices

FDA 510(k) Submission Details - K231986

510(k) Number K231986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2023
Decision Date March 25, 2024
Days to Decision 264 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
116d slower than avg
Panel avg: 148d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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.

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All 105
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