Cleared Traditional

K982712 - RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250

K982712 is an FDA 510(k) clearance for RAPID TRANSFER BLOOD BAG MODEL A-1650, manufactured by Genzyme Surgical Product (Genzyme Biosurgery). The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K982712 · Genzyme Surgical Product (Genzyme Biosurgery) · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
136d
Days
Class 2
Risk

K982712 is an FDA 510(k) clearance for the RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Genzyme Surgical Product (Genzyme Biosurgery) (Fall River, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 136 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 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 Genzyme Surgical Product (Genzyme Biosurgery) devices

FDA 510(k) Submission Details - K982712

510(k) Number K982712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1998
Decision Date December 18, 1998
Days to Decision 136 days
Submission Type Traditional
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
4d faster than avg
Panel avg: 140d · This submission: 136d
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 K982712.
SMARTCELL PROCESSING SYSTEM
K983022 · Harvest Technologies, LLC · Apr 1999
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
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
K982650 · Dideco S.P.A. · 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