Cleared Traditional

K902404 - SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRE...

K902404 is the FDA 510(k) clearance for SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRE... by 3M Company. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K902404 · 3M Company · Cardiovascular device
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Dec 1990
Decision
201d
Days
Class 2
Risk

K902404 is an FDA 510(k) clearance for the SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by 3M Company (Ann Arbor, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 201 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 3M Company devices

Submission Details

510(k) Number K902404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date December 17, 1990
Days to Decision 201 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
76d slower than avg
Panel avg: 125d · This submission: 201d
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 K902404.
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
K915547 · 3M Health Care, Sarns · Sep 1993
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
K915363 · 3M Health Care, Ltd. · Jul 1993
DELPHIN II CENTRIFUGAL SYSTEM
K913176 · 3M Health Care, Sarns · Nov 1991
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