Cleared Traditional

ACCESS SEQUESTRATION SYSTEM (K012406) - FDA 510(k) Clearance

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

K012406 · Interpore Cross Intl. · Anesthesiology device
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Mar 2002
Decision
239d
Days
Class 2
Risk

K012406 is an FDA 510(k) clearance for the ACCESS SEQUESTRATION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 239 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Interpore Cross Intl. devices

Submission Details

510(k) Number K012406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date March 26, 2002
Days to Decision 239 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 139d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 36
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K012406.
autoLog IQ Autotransfusion System
K181954 · Medtronic Perfusion Systems · Aug 2018
AUTOLOG AUTOTRANSFUSION SYSTEM
K093535 · Medtronic, Inc. · Mar 2010
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · Zimmer, Inc. · Oct 2004
CARACELL
K953118 · Medtronic Vascular · Feb 1996
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
K942791 · Sherwood Medical Co. · May 1995
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678 · Baxter Healthcare Corp · Apr 1994