Cleared Abbreviated

K982650 - AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)

K982650 is an FDA 510(k) clearance for AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS), manufactured by Dideco S.P.A.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Abbreviated 510(k) pathway after a 139-day FDA review.

K982650 · Dideco S.P.A. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K982650

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · This submission: 139d
Pathway characteristics
Standards-based clearance path.

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 172
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K982650.
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K982660 · Transfusion Technologies Corp. · Mar 1999
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
K984233 · Fresenius Hemotechnology, Inc. · Feb 1999
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
K982712 · Genzyme Surgical Product (Genzyme Biosurgery) · Dec 1998
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
K982241 · Duxbury Scientific, Inc. · Nov 1998
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
K982755 · Medtronic Blood Management · Aug 1998
AUTOTRANSFUSION APPARTUS (AUTOLOG)
K972894 · Medtronic Blood Management · Apr 1998