Cleared Traditional

K973378 - C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61

K973378 is an FDA 510(k) clearance for C.A.T.S CONTINUOUS AUTOTRANSFUSION SYST..., manufactured by Fresenius USA, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K973378 · Fresenius USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
56d
Days
Class 2
Risk

K973378 is an FDA 510(k) clearance for the C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION.... Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on November 3, 1997 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K973378

510(k) Number K973378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date November 03, 1997
Days to Decision 56 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
84d faster than avg
Panel avg: 140d · This submission: 56d
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 Peers - CAC Apparatus, Autotransfusion

All 175
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K973378.
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