510(k) · Cleared

Cleared

Lifebridge B2T, Model 7001

K090006510(k) TraditionalCleared Oct 15, 2009286-day reviewClass II21 CFR 870.4220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lifebridge Medizintechnik AG · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

Cleared on Oct 15, 2009 as substantially equivalent to K892664 (Bard Cardiosurgery Div, 1990) and 3 other predicates after a 286-day review. Its family tree reaches back 4 generations to 1992. 2 of the 21 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.

Decided: Oct 15, 2009
Review: 286 days
Class: Class II
Product code: DTQ
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K915183 (1992). 15 ancestors in all, the oldest K871131 (1987). 5 later devices descend from it, 3 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
3 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
2 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
1 generation backK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
This deviceK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
Descendant · cites it directly · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK133265 Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
Descendant · cites it directly · 0 of its ownK111384 LifebridgeLifebridge Medizintechnik AG · 2011
Descendant · cites it directly · 0 of its ownK103357 LifebridgeLifebridge Medizintechnik AG · 2010

Class I recalls in this family

K102726 Cardiohelp Systemcites it directly · 2011
K133598 Cardiohelp System2 generations on · 2014

Most influential descendants

Showing 5 of 5 · See all

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · cites it directly2descendants
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 2 generations on0descendants
K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013 · 2 generations on0descendants
K111384LifebridgeLifebridge Medizintechnik AG · 2011 · cites it directly0descendants
K103357LifebridgeLifebridge Medizintechnik AG · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K915183	Sarns 8000 Modular Perfusion System	3M Health Care, Sarns	1992	45
−3	K953901	Sarns 800 Roller Pump	3M Health Care, Sarns	1996	—
−2	K022947	Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1…	Terumo Cardiovascular Systems Corp.	2003	150
−1	K052555	Medtronic Performer TM CPB, Model R51, PCPB	Rand S.R.L.	2006	1
0 (this device)	K090006	Lifebridge B2T, Model 7001	Lifebridge Medizintechnik AG	2009	—
+1	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I
+2	K133598	Cardiohelp System	Maquet Cardiopulmonary, AG	2014	Class I
+2	K133265	Quadrox-IR Adult and Small Adult	Maquet Cardiopulmonary, AG	2013	—
+1	K111384	Lifebridge	Lifebridge Medizintechnik AG	2011	—
+1	K103357	Lifebridge	Lifebridge Medizintechnik AG	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1989	1	0
1990	1	0
1994	1	0
1995	1	0
1996	2	0
1997	1	0
2002	2	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	2	1
2013	1	0
2014	1	1

FIG. 1 — Lineage of K090006, 1992–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DTQ device

#1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K892664	Cardiopulmonary Support (CPS) System Summary page 1 …or and/or control (21 CFR 870.4340) Cardiopulmonary bypass bubble detector (21 CFR 870.4205) PREDICATE DEVICES: Bard (CPS) Cardiopulmonary Support System (K892664) Medtronic Performer CPB and Resting Heart System (K031700, K052555) Jostra MECC System (K023132) Jostra HL-20 Integr…	Bard Cardiosurgery Div	1990	—
*	K031700	Medtronic Resting Heart System, Model AAR1000 and 711 Summary page 1 …bubble detector (21 CFR 870.4205) PREDICATE DEVICES: Bard (CPS) Cardiopulmonary Support System (K892664) Medtronic Performer CPB and Resting Heart System (K031700, K052555) Jostra MECC System (K023132) Jostra HL-20 Integrated Perfusion System (K943803) RotaFlow Centrifugal Pump s…	Medtronic Perfusion Systems	2003	1
*	K052555	Medtronic Performer TM CPB, Model R51, PCPB Summary page 1 …tector (21 CFR 870.4205) PREDICATE DEVICES: Bard (CPS) Cardiopulmonary Support System (K892664) Medtronic Performer CPB and Resting Heart System (K031700, K052555) Jostra MECC System (K023132) Jostra HL-20 Integrated Perfusion System (K943803) RotaFlow Centrifugal Pump system (K9…	Rand S.R.L.	2006	1
*	K023132	Jostra Mecc System Summary page 1 …EDICATE DEVICES: Bard (CPS) Cardiopulmonary Support System (K892664) Medtronic Performer CPB and Resting Heart System (K031700, K052555) Jostra MECC System (K023132) Jostra HL-20 Integrated Perfusion System (K943803) RotaFlow Centrifugal Pump system (K991864) DEVICE DESCRIPTION:…	Jostra AG	2002	—

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102726	Cardiohelp System Class I	Maquet Cardiopulmonary, AG	2011	2
K111384	Lifebridge	Lifebridge Medizintechnik AG	2011	0
K103357	Lifebridge	Lifebridge Medizintechnik AG	2010	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
7 of the 15 ancestors have a recall of any class.
Of its descendants, K102726 (Maquet Cardiopulmonary, AG, 2011) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DTQ devices

DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DTQ

3in 2023

2007high 3 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTQ

292in 2023

2007high 292 (2023) · low 86 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTQ

1in 2024

2007high 42 (2012) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DTQ

1,014in 2025

2007high 1,626 (2012) · low 420 (2007)2025

MAUDE reports naming product code DTQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	9	420
2008	1	—	17	548
2009	3	86	1	589
2010	1	—	17	811
2011	2	—	22	1,081
2012	0	—	42	1,626
2013	0	—	4	906
2014	2	—	1	1,290
2015	2	—	0	1,184
2016	0	—	0	714
2017	2	—	0	527
2018	1	—	1	676
2019	1	—	1 (1)	857
2020	0	—	0	627
2021	2	—	0	729
2022	0	—	1	717
2023	3	292	7 (1)	818
2024	0	—	1	863
2025	0	—	0	1,014
2026	0	—	0	—

What is it indicated for?

The LIFEBRIDGE B2T System is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090006: Lifebridge B2T, Model 7001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090006

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026