Cleared Special

K103357 - LIFEBRIDGE

K103357 is an FDA 510(k) clearance for LIFEBRIDGE, manufactured by Lifebridge Medizintechnik AG. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Special 510(k) pathway after a 41-day FDA review.

K103357 · Lifebridge Medizintechnik AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
41d
Days
Class 2
Risk

K103357 is an FDA 510(k) clearance for the LIFEBRIDGE. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Lifebridge Medizintechnik AG (Bryn Mawr, US). The FDA issued a Cleared decision on December 27, 2010 after a review of 41 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lifebridge Medizintechnik AG devices

FDA 510(k) Submission Details - K103357

510(k) Number K103357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2010
Decision Date December 27, 2010
Days to Decision 41 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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 68
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K103357.
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · Medtronic, Inc. · Jun 2011
LIFEBRIDGE
K111384 · Lifebridge Medizintechnik AG · May 2011
IMPELLA CONTROLLER WITH FLOW CONTROL
K110845 · Abiomed, Inc. · Apr 2011
IMPELLA CONTROLLER
K093801 · Abiomed, Inc. · Jul 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