Cleared Traditional

K912604 - SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF

K912604 is an FDA 510(k) clearance for SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, manufactured by Aries Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K912604 · Aries Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K912604

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
Combination Product No
PCCP Authorized No
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.

KFM Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K912604.
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
K915363 · 3M Health Care, Ltd. · Jul 1993
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
K921550 · St. Jude Medical, Inc. · May 1992
DELPHIN II CENTRIFUGAL SYSTEM
K913176 · 3M Health Care, Sarns · Nov 1991
ARIES MELDICAL MODEL 2100HC HANK CRANK
K903925 · Aries Medical, Inc. · Dec 1990
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · 3M Company · Dec 1990
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198 · 3M Company · Jul 1990