Cleared Traditional

K933625 - BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM

K933625 is an FDA 510(k) clearance for BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM, 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 163-day FDA review.

K933625 · Cobe Cardiovascular, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
163d
Days
Class 2
Risk

K933625 is an FDA 510(k) clearance for the BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM. 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 December 29, 1993 after a review of 163 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 - K933625

510(k) Number K933625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date December 29, 1993
Days to Decision 163 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
23d slower than avg
Panel avg: 140d · This submission: 163d
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 K933625.
PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
K933960 · Cobe Cardiovascular, Inc. · Jun 1994
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678 · Baxter Healthcare Corp · Apr 1994
CELL SAVER 5 SYSTEM
K932890 · Haemonetics Corp. · Jan 1994
DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
K931552 · Davol, Inc. · Oct 1993
BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
K931106 · Deknatel, Inc. · Oct 1993
IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
K925827 · Impra, Inc. · Jul 1993