Cleared Special

K012178 - FRESENIUS C.A.T.S

Also marketed or referenced as:
ATI AUTOTRANSFUSION SET PSQ PLASMA SEQUESTRATION SET PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW

K012178 is an FDA 510(k) clearance for FRESENIUS C.A.T.S, manufactured by Fresenius Hemotechnology, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Special 510(k) pathway after a 11-day FDA review.

K012178 · Fresenius Hemotechnology, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
11d
Days
Class 2
Risk

K012178 is an FDA 510(k) clearance for the FRESENIUS C.A.T.S. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Fresenius Hemotechnology, Inc. (Redmond, US). The FDA issued a Cleared decision on July 23, 2001 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fresenius Hemotechnology, Inc. devices

FDA 510(k) Submission Details - K012178

510(k) Number K012178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date July 23, 2001
Days to Decision 11 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 140d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 154
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