Cleared Traditional

K253422 - OAB Delivery Catheter

K253422 is an FDA 510(k) clearance for OAB Delivery Catheter, manufactured by Cognition Medical Corp.. The device is a Class 2 Neurology device with product code QJP cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K253422 · Cognition Medical Corp. · Neurology device
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Oct 2026
Decision
366d
Days
Class 2
Risk

K253422 is an FDA 510(k) clearance for the OAB Delivery Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Cognition Medical Corp. (Atlanta, US). The FDA issued a Cleared decision on October 2, 2026 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cognition Medical Corp. devices

FDA 510(k) Submission Details - K253422

510(k) Number K253422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2025
Decision Date October 02, 2026
Days to Decision 366 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
217d slower than avg
Panel avg: 149d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJP Device Classification - Class 2, Special Controls

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 Consultant

Mcra, LLC
Robert Herrmann

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 99
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K253422.
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