Cleared Traditional

K904164 - AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED

K904164 is an FDA 510(k) clearance for AUTOVAC AUTOTRANSFUSION SYSTEM, manufactured by Boehringer Laboratories. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K904164 · Boehringer Laboratories · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
360d
Days
Class 2
Risk

K904164 is an FDA 510(k) clearance for the AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 360 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Boehringer Laboratories devices

FDA 510(k) Submission Details - K904164

510(k) Number K904164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date September 06, 1991
Days to Decision 360 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 140d · This submission: 360d
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 K904164.
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · Shiley, Inc. · Nov 1991
DAVOL POST-OP AUTOTRANSFUSION SYSTEM
K913684 · Davol, Inc. · Nov 1991
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
K912019 · Gish Biomedical, Inc. · Oct 1991
PORTABLE AUTO TRANSFUSION SYSTEM 500
K910238 · Electromedics, Inc. · Jun 1991
ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150
K910211 · Deknatel, Inc. · Apr 1991
AUTOWAND(TM) 7XXX SERIES, MODIFICATION
K904888 · Boehringer Laboratories · Jan 1991