Cleared Traditional

K881350 - CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM

K881350 is an FDA 510(k) clearance for CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM, manufactured by Stryker Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K881350 · Stryker Corp. · Anesthesiology device
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Sep 1988
Decision
184d
Days
Class 2
Risk

K881350 is an FDA 510(k) clearance for the CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 184 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 Corp. devices

FDA 510(k) Submission Details - K881350

510(k) Number K881350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1988
Decision Date September 30, 1988
Days to Decision 184 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
44d slower than avg
Panel avg: 140d · This submission: 184d
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 166
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K881350.
PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE
K884844 · Deknatel, Inc. · Jan 1989
CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM
K883934 · Haemonetics Corp. · Dec 1988
PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM
K883082 · Deknatel, Inc. · Oct 1988
ATS BLOOD RECOVERY BAG
K883663 · Atrium Medical Corp. · Sep 1988
BIODYNAMICS AUTOTRANSFUSION RESERVOIR
K881631 · Biodynamics Corp. · Sep 1988
ARGYLE AUTOTRANSFUSION BAG
K882757 · Sherwood Medical Co. · Sep 1988