Cleared Traditional

MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR (K897068) - FDA 510(k) Clearance

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

K897068 · Medtronic Vascular · Cardiovascular device
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Aug 1991
Decision
615d
Days
Class 2
Risk

K897068 is an FDA 510(k) clearance for the MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 615 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K897068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1989
Decision Date August 28, 1991
Days to Decision 615 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
490d slower than avg
Panel avg: 125d · This submission: 615d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 81
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K897068.
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K925626 · Medtronic Vascular · Feb 1993
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
K920889 · Medtronic Vascular · Sep 1992
MINIMAX OXYGENATION SYSTEM
K912655 · Medtronic Vascular · Sep 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
K910107 · Baxter Healthcare Corp · Apr 1991
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
K901624 · Shiley, Inc. · Jul 1990
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
K901249 · Shiley, Inc. · Jun 1990