Cleared Traditional

K963759 - DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS

K963759 is an FDA 510(k) clearance for DIDECO COMPACT-A AND COMPACT-M AUTOTRAN..., manufactured by Sorin Biomedical, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 520-day FDA review.

K963759 · Sorin Biomedical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
520d
Days
Class 2
Risk

K963759 is an FDA 510(k) clearance for the DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Sorin Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 520 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Sorin Biomedical, Inc. devices

FDA 510(k) Submission Details - K963759

510(k) Number K963759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1996
Decision Date February 20, 1998
Days to Decision 520 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 140d · This submission: 520d
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 161
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K963759.
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