510(k) · Cleared
ClearedLbi Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumen Biomedical, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Jun 30, 2006 as substantially equivalent to K032763 (Vascular Solutions, Inc., 2003) and 5 other predicates after a 207-day review. Its family tree reaches back 4 generations to 2001. 10 later devices descend from it.
- Decided
- Jun 30, 2006
- Review
- 207 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K010579 (2001). 11 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 3 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 2 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 1 generation backK050139 Modification to: Export CatheterMedtronic Vascular · 2005
- This deviceK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK071529 Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K071529Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · cites it directly9descendants
- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 2 generations on6descendants
- K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 2 generations on5descendants
- K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · 3 generations on1descendant
- K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −3 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −2 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −1 | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
| 0 (this device) | K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | 2006 | — |
| +1 | K071529 | Xtract Catheter System | Lumen Biomedical, Inc. | 2007 | 1 |
| +2 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| +2 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| +3 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +3 | K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical… | Control Medical Technology | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 QEZ? 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K032763 | Vascular Solutions Pronto Extraction CatheterSummary page 5…Classification: s Catheter, embolectomy « Catheter, embolectomy, 21 CFR §870.5150 e Class I, Product Code - DXE » Panel — Cardiovascular Pronto Extraction Catheter, K032763, K042937, KO51193*, Prediscate K052232 Davices: « Export Aspiration Catheter, K040869, K050139 The Lumen Blomedical Inc. (LBI)… | 2003 |
| * | K042937 | Modification to Vascular Solutions Pronto Extraction CatheterSummary page 5…ication: s Catheter, embolectomy « Catheter, embolectomy, 21 CFR §870.5150 e Class I, Product Code - DXE » Panel — Cardiovascular Pronto Extraction Catheter, K032763, K042937, KO51193*, Prediscate K052232 Davices: « Export Aspiration Catheter, K040869, K050139 The Lumen Blomedical Inc. (LBI) Xtract™Ca… | 2005 |
| * | K051193 | Vascular Solutions Pronto Short Extraction Catheter | 2005 |
| * | K052232 | Vascular Solutions Pronto V3 Extraction CatheterSummary page 5…my « Catheter, embolectomy, 21 CFR §870.5150 e Class I, Product Code - DXE » Panel — Cardiovascular Pronto Extraction Catheter, K032763, K042937, KO51193*, Prediscate K052232 Davices: « Export Aspiration Catheter, K040869, K050139 The Lumen Blomedical Inc. (LBI) Xtract™Catheter System is a single-use,… | 2005 |
| * | K040869 | Export CatheterSummary page 5…Class I, Product Code - DXE » Panel — Cardiovascular Pronto Extraction Catheter, K032763, K042937, KO51193*, Prediscate K052232 Davices: « Export Aspiration Catheter, K040869, K050139 The Lumen Blomedical Inc. (LBI) Xtract™Catheter System is a single-use, 0.014" guidewire compatible, temporary intravasc… | 2004 |
| * | K050139 | Modification to: Export CatheterSummary page 5…Product Code - DXE » Panel — Cardiovascular Pronto Extraction Catheter, K032763, K042937, KO51193*, Prediscate K052232 Davices: « Export Aspiration Catheter, K040869, K050139 The Lumen Blomedical Inc. (LBI) Xtract™Catheter System is a single-use, 0.014" guidewire compatible, temporary intravascular extr… | 2005 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071529 | Xtract Catheter System | 2007 | 9 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K071529 (Lumen Biomedical, Inc., 2007) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K032763.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The LBI Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K053372 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053372: Lbi Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053372
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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