Cleared Traditional

K191717 - Route 92 Medical Sheath System (FDA 510(k) Clearance)

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

K191717 · Route 92 Medical, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2020
Decision
201d
Days
Class 2
Risk

K191717 is an FDA 510(k) clearance for the Route 92 Medical Sheath System. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Route 92 Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 13, 2020 after a review of 201 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - 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 Route 92 Medical, Inc. devices

Submission Details

510(k) Number K191717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date January 13, 2020
Days to Decision 201 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 148d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 887
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