Cleared Traditional

K873807 - AUTOTRANSFUSION APPARATUS

K873807 is the FDA 510(k) clearance for AUTOTRANSFUSION APPARATUS by Biodynamics Corp.. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K873807 · Biodynamics Corp. · Anesthesiology device
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Mar 1988
Decision
173d
Days
Class 2
Risk

K873807 is an FDA 510(k) clearance for the AUTOTRANSFUSION APPARATUS. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Biodynamics Corp. (Houston, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 173 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 Biodynamics Corp. devices

Submission Details

510(k) Number K873807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1987
Decision Date March 09, 1988
Days to Decision 173 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 140d · This submission: 173d
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 54
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K873807.
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · Shiley, Inc. · Jul 1988
DIDECO-SHILEY AUTOTRANS BT 795/AA
K881683 · Shiley, Inc. · Jun 1988
DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK
K881421 · Shiley, Inc. · May 1988
DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT
K872927 · C.R. Bard, Inc. · Oct 1987
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)
K872814 · Shiley, Inc. · Aug 1987
DIDECO-SHILEY BLOOD SEPARATION WASH BOWL
K872160 · Shiley, Inc. · Jul 1987