Cleared Traditional

K913181 - AUTOLOGOUS BLOOD PROCESSING SYSTEM

K913181 is an FDA 510(k) clearance for AUTOLOGOUS BLOOD PROCESSING SYSTEM, manufactured by Lifestream Int'L, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K913181 · Lifestream Int'L, Inc. · Anesthesiology device
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May 1992
Decision
307d
Days
Class 2
Risk

K913181 is an FDA 510(k) clearance for the AUTOLOGOUS BLOOD PROCESSING SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Lifestream Int'L, Inc. (The Woodlands, US). The FDA issued a Cleared decision on May 20, 1992 after a review of 307 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 Lifestream Int'L, Inc. devices

FDA 510(k) Submission Details - K913181

510(k) Number K913181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1991
Decision Date May 20, 1992
Days to Decision 307 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 140d · This submission: 307d
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 139
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K913181.
AUTOVAC 7900 SERIES
K924894 · Boehringer Laboratories · Feb 1993
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
K914119 · Davol, Inc. · Dec 1992
SYSTEM 350
K914053 · Stryker Corp. · Sep 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