510(k) · Decided

Decided

Lbi Embolectomy System

K080901510(k) TraditionalDecided Oct 2, 2008185-day reviewClass II21 CFR 870.5150

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

Lumen Biomedical, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on Oct 2, 2008 as substantially equivalent to K071529 (Lumen Biomedical, Inc., 2007) and 8 other predicates after a 185-day review. Its family tree reaches back 7 generations to 1990. 3 of the 76 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.

Decided: Oct 2, 2008
Review: 185 days
Class: Class II
Product code: QEW
Recalls: None
Predicates: 9

Its longest line of descent runs back 7 generations to K904788 (1990). 69 ancestors in all, the oldest K832023 (1983). 6 later devices descend from it, 1 citing it directly. 3 of the 76 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
6 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
5 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
4 generations backK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
3 generations backK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
2 generations backK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
1 generation backK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
This deviceK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
Descendant · cites it directly · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
Descendant · 2 generations on · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
Descendant · 2 generations on · 1 of its ownK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
Descendant · 3 generations on · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
Descendant · 3 generations on · 0 of its ownK250013 VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012high 2 (2020) · low 0 (2013)2026

Class I recalls in this family

K022145 Over the Wire Embolectomy Catheter, Model 23022 generations back · 2003
K973465 Latis Graft Cleaning Catheter2 generations back · 1998
K970762 Dual Lumen Embolectomy Catheter3 generations back · 1997

Most influential descendants

Showing 5 of 6 · See all

K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · cites it directly5descendants
K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · 2 generations on1descendant
K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology · 2020 · 2 generations on1descendant
K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026 · 3 generations on0descendants
K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K904788	Mewissen Catheter	Boston Scientific Corp	1990	—
−6	K974067	Fountain Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	1998	23
−5	K981417	Squirt Fluid Delivery System	Merit Medical Systems, Inc.	1998	—
−4	K031485	Rinspiration System	Kerberos Proximal Solutions	2003	—
−3	K041291	Rinspiration System	Kerberos Proximal Solutions, Inc.	2004	—
−2	K050130	Kerberos Proximal Solutions Rispiration System	Kerberos Proximal Solutions, Inc.	2005	—
−1	K062275	Rinspiration Catheter System, Models 50135, 550135, P7065, P70135	Kerberos Proximal Solutions, Inc.	2006	—
0 (this device)	K080901	Lbi Embolectomy System	Lumen Biomedical, Inc.	2008	—
+1	K113757	Aspire Max Aspiration Catheter	Control Medical Technology, LLC	2012	—
+2	K220780	ROVO Mechanical Thrombectomy Device	2mg, Inc.	2023	—
+2	K200871	Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical…	Control Medical Technology	2020	—
+3	K253730	RoVo Mechanical Thrombectomy System	Verge Medical, Inc.	2026	—
+3	K250013	VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S…	Control Medical Technology, Inc. / Dba Ventiv Scientific	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1987	1	0
1989	2	0
1991	1	0
1993	2	0
1994	3	0
1995	3	0
1996	3	0
1997	5	1
1998	8	1
1999	2	0
2000	5	0
2001	6	0
2002	7	0
2003	4	1
2004	3	0
2005	4	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2020	2	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K080901, 1990–2026Source: 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.

3 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 QEW device

#1 K213402 Triever24, Triever20score 28.6 · 5 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? (9)

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
*	K071529	Xtract Catheter System Summary page 6 …763) 577-9600 Busincss (763) 577-1044 Fax Maria Brittle Director Regulatory Affairs June 27, 2008 LBI Embolectomy System Catheter, embolectomy Catheter, embolectomy K071529 Xtract Catheter K892410 Fogarty Thru-Lumen Embolectomy catheter K002627 ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsper…	Lumen Biomedical, Inc.	2007	1
*	K892410	Fogarty (R) Thru-Lumen Embolectomy Catheter Summary page 6 …763) 577-1044 Fax Maria Brittle Director Regulatory Affairs June 27, 2008 LBI Embolectomy System Catheter, embolectomy Catheter, embolectomy K071529 Xtract Catheter K892410 Fogarty Thru-Lumen Embolectomy catheter K002627 ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsperation System K040010 F.A…	Baxter Healthcare Corp	1989	1
*	K002627	Atrium Medical Corporation Clearway Ptfe Balloon Catheter Summary page 6 …tory Affairs June 27, 2008 LBI Embolectomy System Catheter, embolectomy Catheter, embolectomy K071529 Xtract Catheter K892410 Fogarty Thru-Lumen Embolectomy catheter K002627 ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsperation System K040010 F.A'S.T. System K991093 MSD Embolectomy basket K9…	Atrium Medical Corp.	2001	—
*	K062275	Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 Summary page 6 …omy System Catheter, embolectomy Catheter, embolectomy K071529 Xtract Catheter K892410 Fogarty Thru-Lumen Embolectomy catheter K002627 ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsperation System K040010 F.A'S.T. System K991093 MSD Embolectomy basket K990639 Hi-Torque Cross-1t 300XT guidewire…	Kerberos Proximal Solutions, Inc.	2006	—
*	K050130	Kerberos Proximal Solutions Rispiration System	Kerberos Proximal Solutions, Inc.	2005	—
*	K040010	Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)… Summary page 6 …eter, embolectomy K071529 Xtract Catheter K892410 Fogarty Thru-Lumen Embolectomy catheter K002627 ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsperation System K040010 F.A'S.T. System K991093 MSD Embolectomy basket K990639 Hi-Torque Cross-1t 300XT guidewire K994358 ATW guidewire The LBI Embole…	Genesis Medical Interventional, Inc.	2004	—
*	K991093	MSD Embolectomy Basket Summary page 6 …9 Xtract Catheter K892410 Fogarty Thru-Lumen Embolectomy catheter K002627 ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsperation System K040010 F.A'S.T. System K991093 MSD Embolectomy basket K990639 Hi-Torque Cross-1t 300XT guidewire K994358 ATW guidewire The LBI Embolectomy System is for use i…	Metamorphic Surgical Devices, LLC	2000	—
*	K990639	Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic… Summary page 6 …ty Thru-Lumen Embolectomy catheter K002627 ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsperation System K040010 F.A'S.T. System K991093 MSD Embolectomy basket K990639 Hi-Torque Cross-1t 300XT guidewire K994358 ATW guidewire The LBI Embolectomy System is for use in removal of fresh, soft emboli…	Guidant Corp.	1999	—
*	K994358	Atw Marker Wire Steerable Guidewire Summary page 6 …ClearWay PTT'E Balloon Catheter K062275, KO50130 Rinsperation System K040010 F.A'S.T. System K991093 MSD Embolectomy basket K990639 Hi-Torque Cross-1t 300XT guidewire K994358 ATW guidewire The LBI Embolectomy System is for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral…	Cordis Corp.	2000	—

Also cleared against K071529: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113757	Aspire Max Aspiration Catheter	Control Medical Technology, LLC	2012	5

Has anything in its family been recalled? (3 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.

K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
13 of the 69 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K113757 (Control Medical Technology, LLC, 2012) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K071529.

How does its category compare?

All QEW devices

QEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · QEW

14in 2025

2007high 23 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEW

58in 2025

2007high 140 (2022) · low 51 (2019)2026

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

Recalls per year · QEW

7in 2022

2007high 7 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · QEW

207in 2025

2007high 322 (2021) · low 0 (2007)2025

MAUDE reports naming product code QEW, 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	0
2008	2	—	0	0
2009	2	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	1	—	0	0
2013	2	—	0	0
2014	2	—	0	0
2015	4	88	0	0
2016	4	63	0	0
2017	2	—	0	0
2018	14	61	0	0
2019	8	51	0	33
2020	16	105	0	197
2021	11	60	0	322
2022	12	140	7 (7)	125
2023	23	102	0	165
2024	14	65	0	162
2025	14	58	0	207
2026	10	74	0	—

What is it indicated for?

The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

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/K080901 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080901: Lbi Embolectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080901

Report an extraction error

Are you the manufacturer?

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