Cleared Traditional

K933960 - PLASMA RECOVERY PROGRAM FOR THE COBE BR...

K933960 is an FDA 510(k) clearance for PLASMA RECOVERY PROGRAM FOR THE COBE BR..., 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 298-day FDA review.

K933960 · Cobe Cardiovascular, Inc. · Anesthesiology device
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Jun 1994
Decision
298d
Days
Class 2
Risk

K933960 is an FDA 510(k) clearance for the PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS 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 June 10, 1994 after a review of 298 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 - K933960

510(k) Number K933960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1993
Decision Date June 10, 1994
Days to Decision 298 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
158d slower than avg
Panel avg: 140d · This submission: 298d
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 K933960.
DAVOL ATS
K931899 · Davol, Inc. · Nov 1994
PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
K926338 · Deknatel, Inc. · Jul 1994
AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
K932093 · Boehringer Laboratories · Jul 1994
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678 · Baxter Healthcare Corp · Apr 1994
CELL SAVER 5 SYSTEM
K932890 · Haemonetics Corp. · Jan 1994
BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
K933625 · Cobe Cardiovascular, Inc. · Dec 1993