Cleared Traditional

K974897 - COBE BRAT 2 SYSTEM WITH MODIFIED STANDA...

K974897 is an FDA 510(k) clearance for COBE BRAT 2 SYSTEM WITH MODIFIED STANDA..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974897 · Cobe Cardiovascular, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
90d
Days
Class 2
Risk

K974897 is an FDA 510(k) clearance for the COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on March 31, 1998 after a review of 90 days - within the typical 510(k) review window.

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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K974897

510(k) Number K974897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1997
Decision Date March 31, 1998
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 137
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K974897.
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K973378 · Fresenius USA, Inc. · Nov 1997