Cleared Traditional

K913773 - COBE BRAT SYSTEMS WITHOUT REINFUSION PR...

K913773 is an FDA 510(k) clearance for COBE BRAT SYSTEMS WITHOUT REINFUSION PR..., 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 157-day FDA review.

K913773 · Cobe Cardiovascular, Inc. · Anesthesiology device
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Jan 1992
Decision
157d
Days
Class 2
Risk

K913773 is an FDA 510(k) clearance for the COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION. 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 27, 1992 after a review of 157 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 - K913773

510(k) Number K913773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date January 27, 1992
Days to Decision 157 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 140d · This submission: 157d
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 K913773.
AUTOVAC 7900 SERIES
K924894 · Boehringer Laboratories · Feb 1993
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
K914119 · Davol, Inc. · Dec 1992
SYSTEM 350
K914053 · Stryker Corp. · Sep 1992
MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950
K912609 · Atrium Medical Corp. · Nov 1991
MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
K912610 · Atrium Medical Corp. · Nov 1991
ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT
K912956 · Atrium Medical Corp. · Nov 1991