510(k) · Cleared
ClearedEasytrak 2 Stylet, Models 4826, 4829, 4832.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation · DRB Stylet, Catheter
Cleared on Feb 13, 2006 as substantially equivalent to K905674 (Cardiac Pacemakers, Inc., 1991) and 1 other predicate after a 115-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 13, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- DRB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952860 (1995). 4 ancestors in all, the oldest K905674 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK952860 The Niner Nitinol GuidewireMicrovena Corp. · 1995
- 2 generations backK983033 Acs HT Balance Middleweight Guide WireGuidant Corp. · 1998
- 1 generation backK021285 HI-Torque Extra S'port GuidewireGuidant Corp. · 2002
- This deviceK052965 Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952860 | The Niner Nitinol Guidewire | Microvena Corp. | 1995 | — |
| −2 | K983033 | Acs HT Balance Middleweight Guide Wire | Guidant Corp. | 1998 | — |
| −1 | K021285 | HI-Torque Extra S'port Guidewire | Guidant Corp. | 2002 | — |
| 0 (this device) | K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832. | Guidant Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K905674 | Lead StyletSummary page 1…ylet Classification Name: Class If Per 21 CER 870.1 380, Catheter Stylet, Cardiovascular Panel Predicate: Stylet Accessory, Model 6602, K905674, cleared January 30, 1991 IRONMAN Guide Wire, Model 6725, K02 1285, cleared May 2, 2… | 1991 |
| * | K021285 | HI-Torque Extra S'port GuidewireSummary page 1…Stylet, Cardiovascular Panel Predicate: Stylet Accessory, Model 6602, K905674, cleared January 30, 1991 IRONMAN Guide Wire, Model 6725, K02 1285, cleared May 2, 2002 5.1. DEVICE DESCRIPTION The EASYTRAK® 2 Stylet is designed for delivery of… | 2002 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K905674.
How does its category compare?
All DRB devicesDRB Stylet, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant EASYTRAK® 2 implantable venous lead in the coronary venous vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052965: Easytrak 2 Stylet, Models 4826, 4829, 4832..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052965
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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