Cleared Traditional

K984586 - FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS

K984586 is an FDA 510(k) clearance for FRESENIUS ATR40 AND ATR120 AUTOTRANSFUS..., manufactured by Fresenius Hemotechnology, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K984586 · Fresenius Hemotechnology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K984586

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
Combination Product No
PCCP Authorized No
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.

DTN Device Classification - Class 2, Special Controls

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 146
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K984586.
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