510(k) · Cleared

Cleared

Medtronic Stylet Kit, Models 6282, 6293, and 6254

K010906510(k) TraditionalCleared Apr 5, 200110-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

Medtronic Vascular · DRB Stylet, Catheter

Cleared on Apr 5, 2001 after a 10-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Apr 5, 2001
Review: 10 days
Class: Class II
Product code: DRB
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.

This deviceK010906 Medtronic Stylet Kit, Models 6282, 6293, and 6254Medtronic Vascular · 2001
Descendant · cites it directly · 1 of its ownK063210 Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478…Medtronic Inc. Cardiac Rhythm Management · 2007 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK143316 Attain Hybrid Guide WireMedtronic, Inc. · 2015

Class I recalls in this family

K063210 Attain Hybrid Guide Wires, Model GWR419378…cites it directly · 2007

Most influential descendants

Showing 2 of 2 · See all

K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 2007 · cites it directly1descendant
K143316Attain Hybrid Guide WireMedtronic, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010906	Medtronic Stylet Kit, Models 6282, 6293, and 6254	Medtronic Vascular	2001	—
+1	K063210	Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488	Medtronic Inc. Cardiac Rhythm Management	2007	Class I
+2	K143316	Attain Hybrid Guide Wire	Medtronic, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	1
2015	1	0

FIG. 1 — Lineage of K010906, 2001–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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

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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063210	Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488 Class I	Medtronic Inc. Cardiac Rhythm Management	2007	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K063210 (Medtronic Inc. Cardiac Rhythm Management, 2007) has gone furthest, with 1 descendant 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

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	2	—	5
2009	1	—	4
2010	0	—	54
2011	0	—	28
2012	0	—	40
2013	0	—	53
2014	1	—	67
2015	0	—	66
2016	0	—	56
2017	1	—	63
2018	0	—	40
2019	2	—	82
2020	0	—	92
2021	0	—	97
2022	1	—	94
2023	0	—	82
2024	0	—	116
2025	0	—	152
2026	0	—	—

https://510kreport.com/device/K010906 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010906: Medtronic Stylet Kit, Models 6282, 6293, and 6254.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010906

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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