Cleared Traditional

K960006 - C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM

K960006 is the FDA 510(k) clearance for C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM by Fresenius AG. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K960006 · Fresenius AG · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
211d
Days
Class 2
Risk

K960006 is an FDA 510(k) clearance for the C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Fresenius AG (Foster, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 211 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 Fresenius AG devices

Submission Details

510(k) Number K960006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date July 31, 1996
Days to Decision 211 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
71d slower than avg
Panel avg: 140d · This submission: 211d
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 47
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K960006.
AUTOLOG AUTOTRANSFUSION SYSTEM
K093535 · Medtronic, Inc. · Mar 2010
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · Zimmer, Inc. · Oct 2004
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K970714 · Stryker Instruments · Dec 1997
CARACELL
K953118 · Medtronic Vascular · Feb 1996
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K952224 · Stryker Instruments · Nov 1995
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
K942791 · Sherwood Medical Co. · May 1995