Cleared Traditional

CATSmart (K180831) - FDA 510(k) Clearance

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

K180831 · Fresenius Kabi AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
255d
Days
Class 2
Risk

K180831 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 December 10, 2018 after a review of 255 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 868.5830 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Kabi AG devices

Submission Details

510(k) Number K180831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date December 10, 2018
Days to Decision 255 days
Submission Type Traditional
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
130d slower than avg
Panel avg: 125d · This submission: 255d
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Fresenius Kabi USA
Barry G. Hicks

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 K180831.
CATSmart, Automated Blood Processing Autotransfusion System
K210089 · Fresenius Kabi AG · Feb 2021
ProCell Surgical Sponge-Blood Recovery Unit
K193361 · Procell Surgical, Inc. · Jun 2020
CATSmart
K192368 · Fresenius Kabi AG · Sep 2019
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