Cleared Traditional

K031468 - TEMPORARY TITANIUM ANEURYSM CLIP

K031468 is an FDA 510(k) clearance for TEMPORARY TITANIUM ANEURYSM CLIP, manufactured by Cardinalhealth. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K031468 · Cardinalhealth · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
42d
Days
Class 2
Risk

K031468 is an FDA 510(k) clearance for the TEMPORARY TITANIUM ANEURYSM CLIP. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on June 20, 2003 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardinalhealth devices

FDA 510(k) Submission Details - K031468

510(k) Number K031468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2003
Decision Date June 20, 2003
Days to Decision 42 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
106d faster than avg
Panel avg: 148d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCH Device Classification - Class 2, Special Controls

Product Code HCH Clip, Aneurysm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5200
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 - HCH Clip, Aneurysm

All 28
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K031468.
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
K060915 · Kirwan Surgical Products, Inc. · Apr 2007
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
K043041 · Aesculap, Inc. · Dec 2004
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc. · Aug 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc. · Mar 2003
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K010908 · Medicon EG · Aug 2001
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc. · Jan 2001