Cleared Traditional

K142321 - Benchmark Intracranial Access System

K142321 is an FDA 510(k) clearance for Benchmark Intracranial Access System, manufactured by Penumbra, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K142321

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.

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 658
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K142321.
Headway 27 Microcatheter
K142449 · MicroVention, Inc. · Mar 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
K141981 · Asahi Intecc Co., Ltd. · Mar 2015
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
K150201 · Spectranetics, Inc. · Feb 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