Cleared Special

K262392 - APRO 35 Swift Catheter

K262392 is an FDA 510(k) clearance for APRO 35 Swift Catheter, manufactured by Alembic, LLC. The device is a Class 2 Neurology device with product code DQY cleared through the Special 510(k) pathway after a 29-day FDA review.

K262392 · Alembic, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
29d
Days
Class 2
Risk

K262392 is an FDA 510(k) clearance for the APRO 35 Swift Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Alembic, LLC (Mountain View, US). The FDA issued a Cleared decision on August 12, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alembic, LLC devices

FDA 510(k) Submission Details - K262392

510(k) Number K262392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2026
Decision Date August 12, 2026
Days to Decision 29 days
Submission Type Special
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
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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.

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All 671
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