Cleared Traditional

K982241 - BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX

K982241 is an FDA 510(k) clearance for BETATRANS INTRAOP I AND II MODEL NUMBER..., manufactured by Duxbury Scientific, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K982241 · Duxbury Scientific, Inc. · Anesthesiology device
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Nov 1998
Decision
158d
Days
Class 2
Risk

K982241 is an FDA 510(k) clearance for the BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Duxbury Scientific, Inc. (Duxbury, US). The FDA issued a Cleared decision on November 30, 1998 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Duxbury Scientific, Inc. devices

FDA 510(k) Submission Details - K982241

510(k) Number K982241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1998
Decision Date November 30, 1998
Days to Decision 158 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
18d slower than avg
Panel avg: 140d · This submission: 158d
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 153
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K982241.
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
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
K982650 · Dideco S.P.A. · Dec 1998
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
K982755 · Medtronic Blood Management · Aug 1998
AUTOTRANSFUSION APPARTUS (AUTOLOG)
K972894 · Medtronic Blood Management · Apr 1998
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
K974897 · Cobe Cardiovascular, Inc. · Mar 1998