510(k) Report

510(k) · Cleared

Cleared

Lead Stylet

K905674510(k) TraditionalCleared Jan 30, 199143-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

Cardiac Pacemakers, Inc. · DRB Stylet, Catheter

Cleared on Jan 30, 1991 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jan 30, 1991
Review
43 days
Class
Class II
Product code
DRB
Recalls
None
Predicates
0

4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared1999: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK905674 Lead StyletCardiac Pacemakers, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK053019 Acuity Steerable Stylet AccessoryGuidant Corporation · 2006
  3. Descendant · cites it directly · 0 of its ownK052965 Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006
  4. Descendant · cites it directly · 0 of its ownK041762 Finishing Wire SupportrakGuidant Corporation · 2004
  5. Descendant · cites it directly · 0 of its ownK992863 Lead Stylet,Models 6505,6506,6507,6508Guidant Corp. · 1999

Most influential descendants

Showing 4 of 4 · See all
  • K053019Acuity Steerable Stylet AccessoryGuidant Corporation · 2006 · cites it directly0descendants
  • K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006 · cites it directly0descendants
  • K041762Finishing Wire SupportrakGuidant Corporation · 2004 · cites it directly0descendants
  • K992863Lead Stylet,Models 6505,6506,6507,6508Guidant Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905674Lead StyletCardiac Pacemakers, Inc.1991—
+1K053019Acuity Steerable Stylet AccessoryGuidant Corporation2006—
+1K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation2006—
+1K041762Finishing Wire SupportrakGuidant Corporation2004—
+1K992863Lead Stylet,Models 6505,6506,6507,6508Guidant Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200410
200620
FIG. 1 — Lineage of K905674, 1991–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053019Acuity Steerable Stylet AccessoryGuidant Corporation20060
K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation20060
K041762Finishing Wire SupportrakGuidant Corporation20040
K992863Lead Stylet,Models 6505,6506,6507,6508Guidant Corp.19990

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?

  • Of its descendants, K053019 (Guidant Corporation, 2006) has gone furthest, with 0 descendants of its own.

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—

More from Cardiac Pacemakers, Inc.

76 FDA decisions under this applicant name. See the company

  • K093969Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc. · 2010
  • K080154Acuity Universal CutterCardiac Pacemakers, Inc. · 20081 recall
  • K934727Replacement Parts for Cpi 6888 Lead TunnelerCardiac Pacemakers, Inc. · 1994
  • K920601Astra T2, Astra T4, Astra T6Cardiac Pacemakers, Inc. · 1992
  • K912379PDT Carryall Transmitter, Various ModelsCardiac Pacemakers, Inc. · 1991

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/K905674 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905674: Lead Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905674

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026