Cleared Traditional

K902059 - AUTOWAND(TM) 7XXX SERIES

K902059 is the FDA 510(k) clearance for AUTOWAND(TM) 7XXX SERIES by Boehringer Laboratories. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K902059 · Boehringer Laboratories · Anesthesiology device
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Jul 1990
Decision
78d
Days
Class 2
Risk

K902059 is an FDA 510(k) clearance for the AUTOWAND(TM) 7XXX SERIES. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on July 24, 1990 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boehringer Laboratories devices

Submission Details

510(k) Number K902059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date July 24, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
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 47
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K902059.
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · Shiley, Inc. · Nov 1991
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
K912019 · Gish Biomedical, Inc. · Oct 1991
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
K900483 · Baxter Healthcare Corp · Aug 1990
COBE CLOSED WOUND DRAINAGE KIT
K902759 · Cobe Laboratories, Inc. · Jul 1990
COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
K902671 · Cobe Laboratories, Inc. · Jul 1990
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
K892443 · Gish Biomedical, Inc. · Nov 1989