Cleared Traditional

K914119 - DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM

K914119 is an FDA 510(k) clearance for DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM, 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 447-day FDA review.

K914119 · Davol, Inc. · Anesthesiology device
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Dec 1992
Decision
447d
Days
Class 2
Risk

K914119 is an FDA 510(k) clearance for the DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Davol, Inc. devices

FDA 510(k) Submission Details - K914119

510(k) Number K914119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date December 03, 1992
Days to Decision 447 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
307d slower than avg
Panel avg: 140d · This submission: 447d
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 147
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K914119.
IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
K925827 · Impra, Inc. · Jul 1993
AUTOTRANSFUSION SUCTION SET
K920618 · Lifestream Int'L, Inc. · Mar 1993
AUTOVAC 7900 SERIES
K924894 · Boehringer Laboratories · Feb 1993
SYSTEM 350
K914053 · Stryker Corp. · Sep 1992
AUTOLOGOUS BLOOD PROCESSING SYSTEM
K913181 · Lifestream Int'L, Inc. · May 1992
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
K913773 · Cobe Cardiovascular, Inc. · Jan 1992