Cleared Traditional

K900601 - SARNS DELPHIN BASE ADAPTER WITH MINI-BA...

K900601 is the FDA 510(k) clearance for SARNS DELPHIN BASE ADAPTER WITH MINI-BA... by 3M Company. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K900601 · 3M Company · Cardiovascular device
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Mar 1990
Decision
48d
Days
Class 2
Risk

K900601 is an FDA 510(k) clearance for the SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY. 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 March 28, 1990 after a review of 48 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 Company devices

Submission Details

510(k) Number K900601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date March 28, 1990
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
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 K900601.
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 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