510(k) Report

510(k) · Cleared

Cleared

Liberator Beacon Tip Locking Stylet

K170298510(k) TraditionalCleared Oct 18, 2017260-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

Cook Incorporated · DRB Stylet, Catheter

Cleared on Oct 18, 2017 as substantially equivalent to K970690 (Cook Pacemaker Corp., 1997) after a 260-day review. Its family tree reaches back 1 generation to 1997.

Decided
Oct 18, 2017
Review
260 days
Class
Class II
Product code
DRB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K970690 (1997). No later device cites it as a predicate yet.

K970690 · Locking Stylet 2 · Cook Pacemaker Corp. · 199719952000200520102015
K970690 · Locking Stylet 2 · Cook Pacemaker Corp. · 19970
  1. Root · 1 generation backK970690 Locking Stylet 2Cook Pacemaker Corp. · 1997
  2. This deviceK170298 Liberator Beacon Tip Locking StyletCook Incorporated · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970690Locking Stylet 2Cook Pacemaker Corp.1997—
0 (this device)K170298Liberator Beacon Tip Locking StyletCook Incorporated2017—
FIG. 1 — Lineage of K170298, 1997–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K970690Locking Stylet 2
Summary page 4
…ion Regulation: 21 CFR §870.1380, Product Code DRB Device Class/Classification Panel: Class II, Cardiovascular Predicate Device: • Locking Stylet 2 (K970690) Device Description: The Liberator® Beacon® Tip Locking Stylet is a specialized stylet that can be inserted through a cardiac…
Cook Pacemaker Corp.1997—

Also cleared against K970690: 2 other devices →

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?

  • Its one ancestor has no recall.
  • 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. 2017, this device’s year, is highlighted.

FDA decisions per year · DRB

1in 2022

2008: 22009: 12014: 12017: 12019: 22022: 1
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

2008: 52009: 42010: 542011: 282012: 402013: 532014: 672015: 662016: 562017: 632018: 402019: 822020: 922021: 972022: 942023: 822024: 1162025: 152
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—05
20091—04
20100—054
20110—028
20120—040
20130—053
20141—067
20150—066
20160—056
20171—063
20180—040
20192—082
20200—092
20210—097
20221—094
20230—082
20240—0116
20250—0152
20260—0—

What is it indicated for?

The Liberator® Beacon® Tip Locking Stylet is intended for use in patients requiring the percutaneous removal of cardiac leads, indwelling catheters and foreign objects, with a central lumen.

Indications for use as stated in the FDA summary.

Also cleared against K970690

2 other devices cite the same predicate.

  • K990713Spectranetics Lead Locking Device (LLD) #1, #2, #3 ListerSpectranetics Corp. · 1999
  • K981061Intravascular Retrieval DeviceMed Institute, Inc. · 1998

More from Cook Incorporated

181 FDA decisions under this applicant name. See the company

  • K233177Nest VT Vitrification DeviceCook Incorporated · 2024
  • K222254Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated · 2023
  • K223098Bakri Essential Postpartum BalloonCook Incorporated · 2022
  • K210734Endovascular Dilator and SetsCook Incorporated · 2021
  • K203670Extra Large Check-Flo IntroducerCook Incorporated · 2021

Recent decisions in DRB

The DRB category page

  • K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022
  • K191469Biotronik StyletsBiotronik, Inc. · 2019
  • K182660GaltTWSGalt Medical Corp. · 2019
  • K142116LLD EZSpectranetics, Inc. · 2014
  • K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009

https://510kreport.com/device/K170298 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170298: Liberator Beacon Tip Locking Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170298

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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