Cleared Traditional

K925626 - MAXIMA PLUS HOLLOW FIBER OXYGENATOR

K925626 is the FDA 510(k) clearance for MAXIMA PLUS HOLLOW FIBER OXYGENATOR by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K925626 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 1993
Decision
91d
Days
Class 2
Risk

K925626 is an FDA 510(k) clearance for the MAXIMA PLUS 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 February 5, 1993 after a review of 91 days - within the typical 510(k) review window.

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: 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 Medtronic Vascular devices

Submission Details

510(k) Number K925626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date February 05, 1993
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 191
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K925626.
SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
K925075 · 3M Health Care, Sarns · Jun 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
K925076 · 3M Health Care, Sarns · Jun 1993
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
K923272 · Cobe Laboratories, Inc. · May 1993
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
K920889 · Medtronic Vascular · Sep 1992
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY
K912079 · 3M Health Care, Sarns · Oct 1991
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
K912920 · 3M Health Care, Ltd. · Sep 1991