Cleared Traditional

K931552 - DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT

K931552 is an FDA 510(k) clearance for DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT, manufactured by Davol, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K931552

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.

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 165
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K931552.
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