Cleared Traditional

K912604 - SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 21...

K912604 is the FDA 510(k) clearance for SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 21... by Aries Medical, Inc.. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K912604 · Aries Medical, Inc. · Cardiovascular device
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Oct 1991
Decision
150d
Days
Class 2
Risk

K912604 is an FDA 510(k) clearance for the SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Aries Medical, Inc. (Chelmsford, US). The FDA issued a Cleared decision on October 28, 1991 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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 Aries Medical, Inc. devices

Submission Details

510(k) Number K912604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date October 28, 1991
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 30
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K912604.
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · Baxter Healthcare Corp · Apr 1996
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
K915547 · 3M Health Care, Sarns · Sep 1993
DELPHIN II CENTRIFUGAL SYSTEM
K913176 · 3M Health Care, Sarns · Nov 1991
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · 3M Company · Dec 1990
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198 · 3M Company · Jul 1990
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
K900601 · 3M Company · Mar 1990