Cleared Traditional

K884659 - SARNS 9000 WITH CENTRIFUGAL PUMP OPTION

K884659 is the FDA 510(k) clearance for SARNS 9000 WITH CENTRIFUGAL PUMP OPTION by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K884659 · 3M Health Care, Sarns · Cardiovascular device
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Jan 1989
Decision
78d
Days
Class 2
Risk

K884659 is an FDA 510(k) clearance for the SARNS 9000 WITH CENTRIFUGAL PUMP OPTION. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Health Care, Sarns devices

Submission Details

510(k) Number K884659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date January 24, 1989
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 42
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K884659.
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
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
K882758 · 3M Health Care, Sarns · Oct 1988
ELECATH PULSATILE PERFUSION PUMP
K854975 · Electro-Catheter Corp. · Jan 1986
MODEL 1861 BLOOD PUMP
K780953 · Medtronic Vascular · Aug 1978