510(k) · Cleared

Cleared

Spectranetics LLD CS, Model 518-039

K043401510(k) TraditionalCleared Mar 16, 200596-day reviewClass II21 CFR 870.1380

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

Spectranetics Corp. · DRB Stylet, Catheter

Cleared on Mar 16, 2005 as substantially equivalent to K990713 (Spectranetics Corp., 1999) after a 96-day review. Its family tree reaches back 2 generations to 1997.

Decided: Mar 16, 2005
Review: 96 days
Class: Class II
Product code: DRB
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K970690 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK970690 Locking Stylet 2Cook Pacemaker Corp. · 1997
1 generation backK990713 Spectranetics Lead Locking Device (LLD) #1, #2, #3 ListerSpectranetics Corp. · 1999
This deviceK043401 Spectranetics LLD CS, Model 518-039Spectranetics Corp. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970690	Locking Stylet 2	Cook Pacemaker Corp.	1997	—
−1	K990713	Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister	Spectranetics Corp.	1999	—
0 (this device)	K043401	Spectranetics LLD CS, Model 518-039	Spectranetics Corp.	2005	—

FIG. 1 — Lineage of K043401, 1997–2005Source: 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 DRB? 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 DRB device

#1 K220280 Arrow Stiffening Styletscore 5.1 · 5 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (1)

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
*	K990713	Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister Summary page 1 …similar in design, construction, indications, target population, nisk analysis, performance, and materials to the predicate devices, the Spectranetics LLD stylets, K99071 3. 4) Device Description The Spectraneties LID E is a percutaneous wire stylets that are placed inside the central lumen of a…	Spectranetics Corp.	1999	—

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 8 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All DRB devices

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

FDA decisions per year · DRB

1in 2022

2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRB

Too few DRB 510(k)s in any year since 2007 to give a median.

Recalls per year · DRB

No recall names DRB since 2007.

Adverse event reports per year · DRB

152in 2025

2007high 152 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	2	—	5
2009	1	—	4
2010	0	—	54
2011	0	—	28
2012	0	—	40
2013	0	—	53
2014	1	—	67
2015	0	—	66
2016	0	—	56
2017	1	—	63
2018	0	—	40
2019	2	—	82
2020	0	—	92
2021	0	—	97
2022	1	—	94
2023	0	—	82
2024	0	—	116
2025	0	—	152
2026	0	—	—

What is it indicated for?

The Spectranetics LLD E is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using the superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.015 - 0.026 inches (0.38 - 0.66 mm) and a length less than 33.5 inches (85 cm).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043401 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043401: Spectranetics LLD CS, Model 518-039.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043401

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