510(k) · Cleared
ClearedLLD EZ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics, Inc. · DRB Stylet, Catheter
Cleared on Aug 12, 2014 after an 8-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 12, 2014
- Review
- 8 days
- Class
- Class II
- Product code
- DRB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All DRB devicesDRB Stylet, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DRB
1in 2022
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 54 |
| 2011 | 0 | — | 0 | 28 |
| 2012 | 0 | — | 0 | 40 |
| 2013 | 0 | — | 0 | 53 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 66 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 1 | — | 0 | 63 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 2 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 92 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 94 |
| 2023 | 0 | — | 0 | 82 |
| 2024 | 0 | — | 0 | 116 |
| 2025 | 0 | — | 0 | 152 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K142116 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142116: LLD EZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142116
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026