Cleared Traditional

K031554 - S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM

K031554 is an FDA 510(k) clearance for S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOU..., manufactured by Genzyme Biosurgery. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K031554 · Genzyme Biosurgery · Anesthesiology device
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Jul 2003
Decision
67d
Days
Class 2
Risk

K031554 is an FDA 510(k) clearance for the S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Genzyme Biosurgery (Fall River, US). The FDA issued a Cleared decision on July 25, 2003 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Genzyme Biosurgery devices

FDA 510(k) Submission Details - K031554

510(k) Number K031554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2003
Decision Date July 25, 2003
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
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 163
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K031554.
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K043127 · Haemonetics Corp. · Jan 2005
EXPRESS AND OASIS CHEST DRAIN
K043140 · Atrium Medical Corp. · Dec 2004
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · Zimmer, Inc. · Oct 2004
DIDECO ELECTA
K020647 · Dideco S.P.A. · Sep 2002
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
K022348 · Interpore Cross Intl. · Aug 2002
ACCESS SEQUESTRATION SYSTEM
K012406 · Interpore Cross Intl. · Mar 2002