Cleared Special

CATSmart (K192368) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192368 · Fresenius Kabi AG · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2019
Decision
28d
Days
Class 2
Risk

K192368 is an FDA 510(k) clearance for the CATSmart. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on September 27, 2019 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 868.5830 - the FDA cardiovascular device oversight 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 Kabi AG devices

Submission Details

510(k) Number K192368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date September 27, 2019
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Fresenius Kabi
Shane Sawall

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 37
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K192368.
FlowSaver Blood Filter
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CATSmart, Automated Blood Processing Autotransfusion System
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ProCell Surgical Sponge-Blood Recovery Unit
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CATSmart
K180831 · Fresenius Kabi AG · Dec 2018
autoLog IQ Autotransfusion System
K181954 · Medtronic Perfusion Systems · Aug 2018
AUTOLOG AUTOTRANSFUSION SYSTEM
K093535 · Medtronic, Inc. · Mar 2010