Cleared Traditional

K081410 - OPTION VENA CAVA FILTER

K081410 is an FDA 510(k) clearance for OPTION VENA CAVA FILTER, manufactured by Rex Medical. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K081410 · Rex Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
380d
Days
Class 2
Risk

K081410 is an FDA 510(k) clearance for the OPTION VENA CAVA FILTER. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Rex Medical (Northborough, US). The FDA issued a Cleared decision on June 4, 2009 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Rex Medical devices

FDA 510(k) Submission Details - K081410

510(k) Number K081410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2008
Decision Date June 04, 2009
Days to Decision 380 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 125d · This submission: 380d
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 44
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K081410.
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K080668 · C.R. Bard, Inc. · Jul 2008
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