Cleared Traditional

EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 (K022071) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022071 · Embol-X, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 95
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K022071.
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
K251744 · Medtronic · Jan 2026
KIDS Arterial Filters
K242953 · Sorin Group Italia S.R.L. · Dec 2024
MICRO Arterial Filters
K242092 · Sorin Group Italia S.R.L. · Nov 2024
OCS Heart Leukocyte Depleting Filter
K231362 · TransMedics, Inc. · Oct 2023
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760 · Medtronic, Inc. · Dec 2012
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K100646 · Medtronic, Inc. · Dec 2010