Cleared Traditional

K914053 - SYSTEM 350

K914053 is the FDA 510(k) clearance for SYSTEM 350 by Stryker Corp.. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K914053 · Stryker Corp. · Anesthesiology device
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Sep 1992
Decision
382d
Days
Class 2
Risk

K914053 is an FDA 510(k) clearance for the SYSTEM 350. 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 25, 1992 after a review of 382 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: Standard predicate-based submission. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K914053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1991
Decision Date September 25, 1992
Days to Decision 382 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 140d · This submission: 382d
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 117
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K914053.
BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
K931106 · Deknatel, Inc. · Oct 1993
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K924894 · Boehringer Laboratories · Feb 1993
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
K914119 · Davol, Inc. · Dec 1992
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
K913773 · Cobe Cardiovascular, Inc. · Jan 1992
MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950
K912609 · Atrium Medical Corp. · Nov 1991
MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
K912610 · Atrium Medical Corp. · Nov 1991