Cleared Traditional

K982755 - MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)

K982755 is an FDA 510(k) clearance for MODIFICATION OF AUTOTRANSFUSION APPARAT..., manufactured by Medtronic Blood Management. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K982755 · Medtronic Blood Management · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
52d
Days
Class 2
Risk

K982755 is an FDA 510(k) clearance for the MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG). Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Medtronic Blood Management (Parker, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 52 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 Medtronic Blood Management devices

FDA 510(k) Submission Details - K982755

510(k) Number K982755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1998
Decision Date August 20, 1998
Days to Decision 52 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
88d faster than avg
Panel avg: 140d · This submission: 52d
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 K982755.
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
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
K982241 · Duxbury Scientific, Inc. · Nov 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
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K970714 · Stryker Instruments · Dec 1997