Cleared Traditional

K881631 - BIODYNAMICS AUTOTRANSFUSION RESERVOIR

K881631 is an FDA 510(k) clearance for BIODYNAMICS AUTOTRANSFUSION RESERVOIR, manufactured by Biodynamics Corp.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K881631

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
Combination Product No
PCCP Authorized No
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.

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 K881631.
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