Cleared Traditional

K133243 - OPTION ELITE VENA CAVA FILTER SYSTEM

K133243 is an FDA 510(k) clearance for OPTION ELITE VENA CAVA FILTER SYSTEM, manufactured by Rex Medical, L.P.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K133243 · Rex Medical, L.P. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
56d
Days
Class 2
Risk

K133243 is an FDA 510(k) clearance for the OPTION ELITE VENA CAVA FILTER SYSTEM. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Rex Medical, L.P. (Great Neck, US). The FDA issued a Cleared decision on December 17, 2013 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - 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: 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 Rex Medical, L.P. devices

FDA 510(k) Submission Details - K133243

510(k) Number K133243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2013
Decision Date December 17, 2013
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 70
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K133243.
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K130366 · C.R. Bard, Inc. · May 2013
CRUX VENA CAVA FILTER SYSTEM
K122585 · Crux Biomedical · Jan 2013
ALN OPTIONAL VANA CAVA FILTER
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