510(k) · Cleared

Cleared

Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister

K990713510(k) TraditionalCleared Oct 22, 1999232-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 Oct 22, 1999 as substantially equivalent to K970690 (Cook Pacemaker Corp., 1997) after a 232-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Oct 22, 1999
Review: 232 days
Class: Class II
Product code: DRB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970690 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970690 Locking Stylet 2Cook Pacemaker Corp. · 1997
This deviceK990713 Spectranetics Lead Locking Device (LLD) #1, #2, #3 ListerSpectranetics Corp. · 1999
Descendant · cites it directly · 0 of its ownK043401 Spectranetics LLD CS, Model 518-039Spectranetics Corp. · 2005

Most influential descendants

Showing 1 of 1 · See all

K043401Spectranetics LLD CS, Model 518-039Spectranetics Corp. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K990713, 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

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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
*	K970690	Locking Stylet 2 Summary page 1 …classified into Class \| or Class Il. Substantial Equivalence: This product is similar in design, composition, and function to the Wilkoff Locking Stylet, 510(k) Number K970690. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990…	Cook Pacemaker Corp.	1997	—

Also cleared against K970690: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K043401	Spectranetics LLD CS, Model 518-039	Spectranetics Corp.	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K043401 (Spectranetics Corp., 2005) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K970690.

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 Lead Locking Devices, LLD™, are intended for use in patients suitable for transvernous removal of chronically iniplanted pacing or defibrillator leads having an inner lumen and using a superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.013 — 0.032 inches (0.33 — 0.81 mm) and a length less than 25.6 inches (65 cm).

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/K990713 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990713: Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990713

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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