510(k) · Cleared

Cleared

Lumend Frontrunner Cto Coronary Catheter

K013284510(k) TraditionalCleared Feb 11, 2002132-day reviewClass II21 CFR 870.1250

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

Lumend, Inc. · DQY Catheter, Percutaneous

Cleared on Feb 11, 2002 as substantially equivalent to K991059 (Spectranetics Corp., 1999) and 3 other predicates after a 132-day review. Its family tree reaches back 2 generations to 1994. 72 later devices descend from it.

Decided: Feb 11, 2002
Review: 132 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K935425 (1994). 5 ancestors in all, the oldest K884647 (1989). 72 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
1 generation backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
This deviceK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002
Descendant · cites it directly · 69 of its ownK023114 Lumend Frontrunner Cto CatheterLumend, Inc. · 2003
Descendant · 2 generations on · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
Descendant · 2 generations on · 32 of its ownK031005 Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
Descendant · 3 generations on · 31 of its ownK033535 Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
Descendant · 3 generations on · 25 of its ownK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2003high 8 (2012) · low 1 (2006)2026

Most influential descendants

Showing 5 of 72 · See all

K023114Lumend Frontrunner Cto CatheterLumend, Inc. · 2003 · cites it directly69descendants
K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · 2 generations on36descendants
K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003 · 2 generations on32descendants
K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004 · 3 generations on31descendants
K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005 · 3 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K935425	Metronic Buchbinder Envoy Percutaneous Catheters	Medtronics Interventional Vascular	1994	—
−1	K991059	Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018…	Spectranetics Corp.	1999	—
0 (this device)	K013284	Lumend Frontrunner Cto Coronary Catheter	Lumend, Inc.	2002	—
+1	K023114	Lumend Frontrunner Cto Catheter	Lumend, Inc.	2003	—
+2	K040067	Clirpath Excimer Laser Catheter	Spectranetics Corp.	2004	—
+2	K031005	Lumend Frontrunner GW Cto Catheter	Lumend, Inc.	2003	—
+3	K033535	Lumend Frontrunner Cto Catheter and Accessories	Lumend, Inc.	2004	—
+3	K043465	2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011	Spectranetics Corp.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	3	0
2006	1	0
2007	2	0
2008	1	0
2009	1	0
2010	2	0
2011	4	0
2012	8	0
2013	1	0
2014	4	0
2015	3	0
2016	3	0
2017	6	0
2018	3	0
2019	1	0
2020	4	0
2021	2	0
2022	6	0
2023	6	0
2024	2	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K013284, 1994–2026Source: 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.

Planning a device in DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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
*	K991059	Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support… Summary page 1 …quivalent in intended use and/or method of operation to a combination of the following predicate devices: 1. Spectranetics Support Catheter Spectranetics Corp. — 510(k) K991059 Magnum-Meier™ Recanalization Guidewire Schneider AG / Pfizer Hospital Prod. — 510¢k) K911547 3. Clyde™ Coronary Guidewire Schnei…	Spectranetics Corp.	1999	—
*	K911547	Magnum-Meier Recanalization Guidewire Summary page 1 …ate devices: 1. Spectranetics Support Catheter Spectranetics Corp. — 510(k) K991059 Magnum-Meier™ Recanalization Guidewire Schneider AG / Pfizer Hospital Prod. — 510¢k) K911547 3. Clyde™ Coronary Guidewire Schneider (Europe) AG / Pfizer Hospital Prod. Group — 510(k) K970528 4. USCI Adjustable Tip Guide…	Schneider Intl., Ltd.	1991	—
*	K970528	Clyde Coronary Guidewire Summary page 1 …Recanalization Guidewire Schneider AG / Pfizer Hospital Prod. — 510¢k) K911547 3. Clyde™ Coronary Guidewire Schneider (Europe) AG / Pfizer Hospital Prod. Group — 510(k) K970528 4. USCI Adjustable Tip Guide Wire C.R. Bard, Inc. —- 510(k) K884647 Device Description: The LuMend Frontrunner™ is a sterile s…	Schneider (Europe) GmbH	1997	—
*	K884647	Usci Adjustable Tip Guide Wire Summary page 1 …) K911547 3. Clyde™ Coronary Guidewire Schneider (Europe) AG / Pfizer Hospital Prod. Group — 510(k) K970528 4. USCI Adjustable Tip Guide Wire C.R. Bard, Inc. —- 510(k) K884647 Device Description: The LuMend Frontrunner™ is a sterile single-use percutaneous coronary catheter consisting of a handle assem…	C.R. Bard, Inc.	1989	—

Also cleared against K991059: 6 other devices →

What descends from it? (72)

See all 72

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

Number	Device	Applicant	Decided	Descendants
K023114	Lumend Frontrunner Cto Catheter	Lumend, Inc.	2003	69
K102725	Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…	Bridge Medical, Inc.	2011	11
K070212	CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…	Ovalum, Ltd.	2007	1

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 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K023114 (Lumend, Inc., 2003) has gone furthest, with 69 descendants of its own.
6 other devices also cite its predicate K991059.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.

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/K013284 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013284: Lumend Frontrunner Cto Coronary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013284

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026