Cleared Traditional

K952224 - STRYKER CONSTAVAC BLOOD CONSERVATION SY...

K952224 is the FDA 510(k) clearance for STRYKER CONSTAVAC BLOOD CONSERVATION SY... by Stryker Instruments. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K952224 · Stryker Instruments · Anesthesiology device
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Nov 1995
Decision
189d
Days
Class 2
Risk

K952224 is an FDA 510(k) clearance for the STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII). Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on November 17, 1995 after a review of 189 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 Stryker Instruments devices

Submission Details

510(k) Number K952224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1995
Decision Date November 17, 1995
Days to Decision 189 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
49d slower than avg
Panel avg: 140d · This submission: 189d
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 46
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K952224.
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · Zimmer, Inc. · Oct 2004
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K970714 · Stryker Instruments · Dec 1997
CARACELL
K953118 · Medtronic Vascular · Feb 1996
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
K942791 · Sherwood Medical Co. · May 1995
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678 · Baxter Healthcare Corp · Apr 1994
SYSTEM 350
K914053 · Stryker Corp. · Sep 1992