Cleared Traditional

K213390 - Benchmark BMX96 Access System

K213390 is the FDA 510(k) clearance for Benchmark BMX96 Access System by Penumbra, Inc.. It is a Class 2 Neurology device (product code QJP) cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K213390 · Penumbra, Inc. · Neurology device
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Aug 2022
Decision
307d
Days
Class 2
Risk

K213390 is an FDA 510(k) clearance for the Benchmark BMX96 Access System. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on August 18, 2022 after a review of 307 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 Penumbra, Inc. devices

Submission Details

510(k) Number K213390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2021
Decision Date August 18, 2022
Days to Decision 307 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
159d slower than avg
Panel avg: 148d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K213390.
Branchor Balloon Guide Catheter
K221951 · Asahi Intecc Co., Ltd. · Oct 2022
Route 92 Medical Full Length 070 Access System
K222743 · Route 92 Medical, Inc. · Oct 2022
Millipede 088 Access Catheter
K214048 · Perfuze, Ltd. · Sep 2022
Minjie Catheter System
K212288 · Kai Medtech, LLC · Jun 2022
Distal Access Catheter
K213065 · Guangzhou Easycess Medical Co.,Ltd · May 2022
Benchmark Intracranial Access System
K212838 · Penumbra, Inc. · May 2022