Cleared Traditional

K894255 - ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP

K894255 is an FDA 510(k) clearance for ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP, manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K894255 · St. Jude Medical, Inc. · Cardiovascular device
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Sep 1989
Decision
98d
Days
Class 2
Risk

K894255 is an FDA 510(k) clearance for the ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 98 days - within the typical 510(k) review window.

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 St. Jude Medical, Inc. devices

FDA 510(k) Submission Details - K894255

510(k) Number K894255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1989
Decision Date September 26, 1989
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 55
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K894255.
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
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
K884659 · 3M Health Care, Sarns · Jan 1989
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
K882758 · 3M Health Care, Sarns · Oct 1988
ELECATH PULSATILE PERFUSION PUMP
K854975 · Electro-Catheter Corp. · Jan 1986