Cleared Traditional

K962689 - COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SY...

K962689 is an FDA 510(k) clearance for COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SY..., 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 201-day FDA review.

K962689 · Cobe Cardiovascular, Inc. · Anesthesiology device
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Jan 1997
Decision
201d
Days
Class 2
Risk

K962689 is an FDA 510(k) clearance for the COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PRO.... 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 January 28, 1997 after a review of 201 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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K962689

510(k) Number K962689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1996
Decision Date January 28, 1997
Days to Decision 201 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
61d slower than avg
Panel avg: 140d · This submission: 201d
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 K962689.
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
K973378 · Fresenius USA, Inc. · Nov 1997
STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
K973627 · Cobe Cardiovascular, Inc. · Nov 1997
PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K963850 · Deknatel, Inc. · Apr 1997
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
K964070 · Deknatel, Inc. · Dec 1996
PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
K963098 · Deknatel, Inc. · Nov 1996
AUTOVAC BP SYSTE, 2000 SERIES
K955010 · Boehringer Laboratories · Jun 1996