Cleared Traditional

K012406 - ACCESS SEQUESTRATION SYSTEM

K012406 is an FDA 510(k) clearance for ACCESS SEQUESTRATION SYSTEM, manufactured by Interpore Cross Intl.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K012406 · Interpore Cross Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K012406

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 140d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

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 167
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K012406.
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · Zimmer, Inc. · Oct 2004
DIDECO ELECTA
K020647 · Dideco S.P.A. · Sep 2002
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
K022348 · Interpore Cross Intl. · Aug 2002
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
K014187 · Boehringer Laboratories · Feb 2002
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
K014083 · Haemonetics Corp. · Jan 2002
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
K993581 · Haemonetics Corp. · Nov 1999