Cleared Traditional

K912019 - ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSI...

K912019 is an FDA 510(k) clearance for ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSI..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K912019 · Gish Biomedical, Inc. · Anesthesiology device
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Oct 1991
Decision
154d
Days
Class 2
Risk

K912019 is an FDA 510(k) clearance for the ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 154 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K912019

510(k) Number K912019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1991
Decision Date October 08, 1991
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 K912019.
ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT
K912956 · Atrium Medical Corp. · Nov 1991
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · Shiley, Inc. · Nov 1991
DAVOL POST-OP AUTOTRANSFUSION SYSTEM
K913684 · Davol, Inc. · Nov 1991
AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED
K904164 · Boehringer Laboratories · Sep 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