Cleared Traditional

K982755 - MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982755 · Medtronic Blood Management · Anesthesiology device
Download Printable Device Report (PDF)
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

Submission Details

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
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 139d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 194
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K982755.
XTRA Collection sets
K241236 · Sorin Group Italia S.R.L. · Aug 2024
Aventus Clot Management System
K240426 · Inquis Medical · May 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · Sorin Group Italia S.R.L. · Apr 2024
FlowSaver Blood Return System (80-101)
K231782 · Inari Medical, Inc. · Jul 2023
FlowSaver Blood Return System
K221483 · Inari Medical, Inc. · Feb 2023
FlowSaver Blood Filter
K210176 · Inari Medical · Jul 2021