510(k) · Cleared
ClearedLifebridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifebridge Medizintechnik AG · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Dec 27, 2010 as substantially equivalent to K090006 (Lifebridge Medizintechnik AG, 2009) and 2 other predicates after a 41-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Dec 27, 2010
- Review
- 41 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K915183 (1992). 18 ancestors in all, the oldest K871131 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 4 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 3 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 2 generations backK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
- 1 generation backK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
- This deviceK103357 LifebridgeLifebridge Medizintechnik AG · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −4 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −3 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −2 | K052555 | Medtronic Performer TM CPB, Model R51, PCPB | Rand S.R.L. | 2006 | 1 |
| −1 | K090006 | Lifebridge B2T, Model 7001 | Lifebridge Medizintechnik AG | 2009 | — |
| 0 (this device) | 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 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
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.
Planning a device in KFM? 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 KFM device
- #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K090006 | Lifebridge B2T, Model 7001Summary page 1…bypass level sensing monitor and/or control (21 CFR 870.4340) Cardiopulmonary bypass bubble detector (21 CFR 870.4205) PREDICATE DEVICES: Lifebridge B2T System K090006 Medtronic Affinity NT oxygenator with Carmeda Bioactive Surface K000430 Avecor Affinity Hollow Fiber oxygenator with Trilli… | 2009 |
| * | K000430 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive…Summary page 1…onary bypass bubble detector (21 CFR 870.4205) PREDICATE DEVICES: Lifebridge B2T System K090006 Medtronic Affinity NT oxygenator with Carmeda Bioactive Surface K000430 Avecor Affinity Hollow Fiber oxygenator with Trillium Biopassive Surface K973760 DEVICE DESCRIPTION: The LIFEBRIDGE SYS… | 2000 |
| * | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceSummary page 1…B2T System K090006 Medtronic Affinity NT oxygenator with Carmeda Bioactive Surface K000430 Avecor Affinity Hollow Fiber oxygenator with Trillium Biopassive Surface K973760 DEVICE DESCRIPTION: The LIFEBRIDGE SYSTEM is a compact, pre-assembled, modular system consisting of: 1. Patient module… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 9 of the 18 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090006.
How does its category compare?
All KFM devicesKFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KFM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KFM
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KFM
2in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KFM
249in 2025
MAUDE reports naming product code KFM, 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 | 0 | — | 0 | 60 |
| 2008 | 4 | 194 | 2 | 62 |
| 2009 | 5 | 184 | 4 | 85 |
| 2010 | 3 | 109 | 2 | 81 |
| 2011 | 7 | 16 | 1 | 57 |
| 2012 | 0 | — | 5 | 82 |
| 2013 | 2 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 347 |
| 2015 | 0 | — | 0 | 299 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 121 |
| 2018 | 0 | — | 1 | 176 |
| 2019 | 3 | 147 | 3 (1) | 311 |
| 2020 | 3 | 30 | 0 | 437 |
| 2021 | 3 | 534 | 0 | 446 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 3 | 30 | 0 | 346 |
| 2024 | 0 | — | 2 | 296 |
| 2025 | 2 | — | 0 | 249 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIFEBRIDGE 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/K103357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103357: Lifebridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103357
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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