Cleared Traditional

K963758 - CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE

K963758 is an FDA 510(k) clearance for CODE 150 BLOOD COMPONENT COLLECTION SET..., 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.

K963758 · Sorin Biomedical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
520d
Days
Class 2
Risk

K963758 is an FDA 510(k) clearance for the CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE. 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 - K963758

510(k) Number K963758 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 K963758.
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