Cleared Traditional

K093801 - IMPELLA CONTROLLER

K093801 is an FDA 510(k) clearance for IMPELLA CONTROLLER, manufactured by Abiomed, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K093801 · Abiomed, Inc. · Cardiovascular device
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Jul 2010
Decision
210d
Days
Class 2
Risk

K093801 is an FDA 510(k) clearance for the IMPELLA CONTROLLER. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on July 8, 2010 after a review of 210 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 Abiomed, Inc. devices

FDA 510(k) Submission Details - K093801

510(k) Number K093801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2009
Decision Date July 08, 2010
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
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 74
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K093801.
LIFEBRIDGE
K111384 · Lifebridge Medizintechnik AG · May 2011
IMPELLA CONTROLLER WITH FLOW CONTROL
K110845 · Abiomed, Inc. · Apr 2011
LIFEBRIDGE
K103357 · Lifebridge Medizintechnik AG · Dec 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · Medtronic, Inc. · Jun 2010
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515 · Maquet Cardiopulmonary, AG · Dec 2009
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
K090051 · Levitronix, LLC · Oct 2009