Cleared Traditional

K202391 - DIR 800 (FDA 510(k) Clearance)

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

K202391 · Aesculap, Inc. · Neurology device
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Jan 2021
Decision
153d
Days
Class 2
Risk

K202391 is an FDA 510(k) clearance for the DIR 800. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 21, 2021 after a review of 153 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 Aesculap, Inc. devices

Submission Details

510(k) Number K202391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2020
Decision Date January 21, 2021
Days to Decision 153 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
5d slower than avg
Panel avg: 148d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - IZI System, X-ray, Angiographic

All 196
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