Cleared Special

K122585 - CRUX VENA CAVA FILTER SYSTEM

K122585 is an FDA 510(k) clearance for CRUX VENA CAVA FILTER SYSTEM, manufactured by Crux Biomedical. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Special 510(k) pathway after a 146-day FDA review.

K122585 · Crux Biomedical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
146d
Days
Class 2
Risk

K122585 is an FDA 510(k) clearance for the CRUX VENA CAVA FILTER SYSTEM. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Crux Biomedical (Menlo Park, US). The FDA issued a Cleared decision on January 17, 2013 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122585

510(k) Number K122585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2012
Decision Date January 17, 2013
Days to Decision 146 days
Submission Type Special
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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

DTK Device Classification - Class 2, Special Controls

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
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 - DTK Filter, Intravascular, Cardiovascular

All 78
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K122585.
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
K140286 · Cordis, A Johnson & Johnson Co. · Mar 2014
OPTION ELITE VENA CAVA FILTER SYSTEM
K133243 · Rex Medical, L.P. · Dec 2013
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366 · C.R. Bard, Inc. · May 2013
ALN OPTIONAL VANA CAVA FILTER
K113124 · Aln Implants Chirurgicaux · Nov 2012
CRUX VENA CAVA FILTER SYSTEM
K120402 · Crux Biomedical · Jul 2012
COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
K121629 · William Cook Europe Aps · Jul 2012
K122585 · CRUX VENA CAVA FILTER SYSTEM
Download PDF FDA Summary Crux Biomedical