Cleared Traditional

K022071 - EMBOL-X AORTIC FILTERS

K022071 is the FDA 510(k) clearance for EMBOL-X AORTIC FILTERS by Embol-X, Inc.. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K022071 · Embol-X, Inc. · Cardiovascular device
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Feb 2003
Decision
233d
Days
Class 2
Risk

K022071 is an FDA 510(k) clearance for the EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF260.... Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Embol-X, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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 Embol-X, Inc. devices

Submission Details

510(k) Number K022071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2002
Decision Date February 14, 2003
Days to Decision 233 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
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 59
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K022071.
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946 · Edwards Lifesciences, LLC · Nov 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128 · Terumo Cardiovascular Systems Corp. · Aug 2003
GISH ARTERIAL FILTER WITH GBS COATING
K023833 · Gish Biomedical, Inc. · Mar 2003
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · Terumo Cardiovascular Systems Corp. · Jul 2001
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
K002493 · Cobe Cardiovascular, Inc. · Nov 2000
CAPIOX ARTERIAL FILTER
K002026 · Terumo Medical Corp. · Sep 2000