Cleared Abbreviated

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) (K982650) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K982650 · Dideco S.P.A. · Anesthesiology device
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Dec 1998
Decision
139d
Days
Class 2
Risk

K982650 is an FDA 510(k) clearance for the AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS). Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Dideco S.P.A. (North Attleboro, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dideco S.P.A. devices

Submission Details

510(k) Number K982650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1998
Decision Date December 16, 1998
Days to Decision 139 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · This submission: 139d
Pathway characteristics
Standards-based clearance path.

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 38
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K982650.
autoLog IQ Autotransfusion System
K181954 · Medtronic Perfusion Systems · Aug 2018
AUTOLOG AUTOTRANSFUSION SYSTEM
K093535 · Medtronic, Inc. · Mar 2010
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · Zimmer, Inc. · Oct 2004
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