Cleared Traditional

K090006 - LIFEBRIDGE B2T

K090006 is the FDA 510(k) clearance for LIFEBRIDGE B2T by Lifebridge Medizintechnik AG. It is a Class 2 Cardiovascular device (product code DTQ) cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K090006 · Lifebridge Medizintechnik AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
286d
Days
Class 2
Risk

K090006 is an FDA 510(k) clearance for the LIFEBRIDGE B2T, MODEL 7001. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Lifebridge Medizintechnik AG (Bryn Mawr, US). The FDA issued a Cleared decision on October 15, 2009 after a review of 286 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Lifebridge Medizintechnik AG devices

Submission Details

510(k) Number K090006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date October 15, 2009
Days to Decision 286 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 125d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 23
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K090006.
CARDIOHELP SYSTEM
K133598 · Maquet Cardiopulmonary, AG · May 2014
ADVANCED PERFUSION SYSTEM 1
K131041 · Terumo Cardiovascular Systems Corp. · Feb 2014
CARDIOHELP SYSTEM
K102726 · Maquet Cardiopulmonary, AG · Apr 2011
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183 · 3M Health Care, Sarns · Jul 1992
SARNS 9000 HEART-LUNG CONSOLE
K871131 · 3M Health Care, Sarns · May 1987