Cleared Traditional

FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS (K984586) - FDA 510(k) Clearance

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

K984586 · Fresenius Hemotechnology, Inc. · Cardiovascular device
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Jun 1999
Decision
187d
Days
Class 2
Risk

K984586 is an FDA 510(k) clearance for the FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Fresenius Hemotechnology, Inc. (Concord, US). The FDA issued a Cleared decision on June 29, 1999 after a review of 187 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Hemotechnology, Inc. devices

Submission Details

510(k) Number K984586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1998
Decision Date June 29, 1999
Days to Decision 187 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 54
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K984586.
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