Cleared Traditional

K881631 - BIODYNAMICS AUTOTRANSFUSION RESERVOIR

K881631 is the FDA 510(k) clearance for BIODYNAMICS AUTOTRANSFUSION RESERVOIR by Biodynamics Corp.. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K881631 · Biodynamics Corp. · Anesthesiology device
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Sep 1988
Decision
148d
Days
Class 2
Risk

K881631 is an FDA 510(k) clearance for the BIODYNAMICS AUTOTRANSFUSION RESERVOIR. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Biodynamics Corp. (Houston, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 148 days - within the typical 510(k) review window.

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 K881631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1988
Decision Date September 09, 1988
Days to Decision 148 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 140d · This submission: 148d
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 K881631.
HARVESTING TUBE
K892857 · Conmedcorp · Jun 1989
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM
K884564 · Shiley, Inc. · May 1989
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
K881350 · Stryker Corp. · Sep 1988
ARGYLE AUTOTRANSFUSION BAG
K882757 · Sherwood Medical Co. · Sep 1988
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · Shiley, Inc. · Jul 1988
DIDECO-SHILEY AUTOTRANS BT 795/AA
K881683 · Shiley, Inc. · Jun 1988