Cleared Traditional

K931552 - DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT

K931552 is the FDA 510(k) clearance for DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT by Davol, Inc.. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K931552 · Davol, Inc. · Anesthesiology device
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Oct 1993
Decision
193d
Days
Class 2
Risk

K931552 is an FDA 510(k) clearance for the DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on October 8, 1993 after a review of 193 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 Davol, Inc. devices

Submission Details

510(k) Number K931552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1993
Decision Date October 08, 1993
Days to Decision 193 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
53d slower than avg
Panel avg: 140d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K931552.
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
BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
K933625 · Cobe Cardiovascular, Inc. · Dec 1993
BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
K931106 · Deknatel, Inc. · Oct 1993
AUTOVAC 7900 SERIES
K924894 · Boehringer Laboratories · Feb 1993
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
K914119 · Davol, Inc. · Dec 1992