Cleared Traditional

K261938 - APRO 88 Catheter

K261938 is an FDA 510(k) clearance for APRO 88 Catheter, manufactured by Alembic, LLC. The device is a Class 2 Neurology device with product code QJP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K261938 · Alembic, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
118d
Days
Class 2
Risk

K261938 is an FDA 510(k) clearance for the APRO 88 Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Alembic, LLC (Mountain View, US). The FDA issued a Cleared decision on October 6, 2026 after a review of 118 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K261938

510(k) Number K261938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2026
Decision Date October 06, 2026
Days to Decision 118 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
31d faster than avg
Panel avg: 149d · This submission: 118d
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 Peers - QJP Catheter, Percutaneous, Neurovasculature

All 101
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K261938.
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K261938 · APRO 88 Catheter
Download PDF FDA Summary Alembic, LLC