Cleared Traditional

K160735 - CATSmart

K160735 is an FDA 510(k) clearance for CATSmart, manufactured by Fresenius Kabi AG. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K160735 · Fresenius Kabi AG · Anesthesiology device
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Sep 2016
Decision
183d
Days
Class 2
Risk

K160735 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 16, 2016 after a review of 183 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 Kabi AG devices

FDA 510(k) Submission Details - K160735

510(k) Number K160735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2016
Decision Date September 16, 2016
Days to Decision 183 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
43d slower than avg
Panel avg: 140d · This submission: 183d
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 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 168
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K160735.
CATSmart
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Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
K162423 · Haemonetics Corporation · Jan 2017
Haemonetics Cell Saver Elite Autotransfusion System
K160197 · Haemonetics Corporation · May 2016
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140205 · Teleflexmedical, Inc. · Oct 2014
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140197 · Teleflexmedical, Inc. · Oct 2014