Cleared Traditional

K142321 - Benchmark Intracranial Access System

K142321 is the FDA 510(k) clearance for Benchmark Intracranial Access System by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K142321 · Penumbra, Inc. · Cardiovascular device
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Jan 2015
Decision
160d
Days
Class 2
Risk

K142321 is an FDA 510(k) clearance for the Benchmark Intracranial Access System. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on January 26, 2015 after a review of 160 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Penumbra, Inc. devices

Submission Details

510(k) Number K142321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2014
Decision Date January 26, 2015
Days to Decision 160 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 125d · This submission: 160d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 461
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K142321.
SOFIA 6F Catheter
K150366 · MicroVention, Inc. · Mar 2015
Headway 27 Microcatheter
K142449 · MicroVention, Inc. · Mar 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
K141981 · Asahi Intecc Co., Ltd. · Mar 2015
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
K142235 · St Jude Medical · Dec 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · St Jude Medical · Dec 2014
TURNPIKE CATHETER
K142065 · Vascular Solutions, Inc. · Nov 2014