510(k) Report

510(k) · Cleared

Cleared

Acuity Steerable Stylet Accessory

K053019510(k) TraditionalCleared Mar 3, 2006128-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

Guidant Corporation · DRB Stylet, Catheter

Cleared on Mar 3, 2006 as substantially equivalent to K905674 (Cardiac Pacemakers, Inc., 1991) and 1 other predicate after a 128-day review. Its family tree reaches back 1 generation to 1984.

Decided
Mar 3, 2006
Review
128 days
Class
Class II
Product code
DRB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K843060 (1984). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 1 other ancestorK843060 · Sentra · Cardiac Pacemakers, Inc. · 1984198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K843060 · Sentra · Cardiac Pacemakers, Inc. · 19840
  1. Root · 1 generation backK843060 SentraCardiac Pacemakers, Inc. · 1984
  2. This deviceK053019 Acuity Steerable Stylet AccessoryGuidant Corporation · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K843060SentraCardiac Pacemakers, Inc.1984—
0 (this device)K053019Acuity Steerable Stylet AccessoryGuidant Corporation2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
FIG. 1 — Lineage of K053019, 1984–2006Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K905674Lead Stylet
Summary page 1
…on Name: Class II Per 21 CFR 870.1380, Catheter Stylet, Cardiovascular Panel Predicate: · Firm Straight 0.016 Stylet, Model 6602, K905674, cleared January 30, 1991 Tapered 0.016 Stylet, Model 6583, K843060, cleared…
Cardiac Pacemakers, Inc.1991—
*K843060Sentra
Summary page 1
…· Firm Straight 0.016 Stylet, Model 6602, K905674, cleared January 30, 1991 Tapered 0.016 Stylet, Model 6583, K843060, cleared Septemiv, 20, 1984 1.1. DEVICE DESCRIPTION The ACUITY Steerable Stylet is intended for d…
Cardiac Pacemakers, Inc.1984—

Also cleared against K905674: 3 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?

  • None of the 2 ancestors has a recall.
  • 3 other devices also cite its predicate K905674.

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

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?

For use with compatible, transvenous, left ventricular, pace/sense leads

Indications for use as stated in the FDA summary.

Also cleared against K905674

3 other devices cite the same predicate.

  • K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006
  • K041762Finishing Wire SupportrakGuidant Corporation · 2004
  • K992863Lead Stylet,Models 6505,6506,6507,6508Guidant Corp. · 1999

More from Guidant Corporation

15 FDA decisions under this applicant name. See the company

  • K060449HI-Torque Advance and Advance Lite Guide WireGuidant Corporation · 2006
  • K053459Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006
  • K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
  • K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006
  • K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 20051 Class I recall

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
  • K170298Liberator Beacon Tip Locking StyletCook Incorporated · 2017
  • K142116LLD EZSpectranetics, Inc. · 2014

https://510kreport.com/device/K053019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053019: Acuity Steerable Stylet Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053019

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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