510(k) · Cleared

Cleared

Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078

K090163510(k) TraditionalCleared Apr 1, 200969-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

Cleared on Apr 1, 2009 as substantially equivalent to P960030 (Abbott Medical, 1998) and 3 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1996. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Apr 1, 2009
Review: 69 days
Class: Class II
Product code: DRB
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to P950022 (1996). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backP950022 TVL (TM) Lead SystemAbbott Medical · 1996 · Recalled (Class I)
This deviceK090163 Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009
Descendant · cites it directly · 0 of its ownK191469 Biotronik StyletsBiotronik, Inc. · 2019

Class I recalls in this family

P950022 TVL (TM) Lead Systemdirect predicate · 1996

Most influential descendants

Showing 1 of 1 · See all

K191469Biotronik StyletsBiotronik, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P950022	TVL (TM) Lead System	Abbott Medical	1996	Class I
0 (this device)	K090163	Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078	St Jude Medical	2009	—
+1	K191469	Biotronik Stylets	Biotronik, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K090163, 1996–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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? (4)

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	Applicant	Decided	Recalls
*	P960030	Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads Summary page 1 …commercially available. SJM Stylet Model Approved with PMA Number 4060, 4062 and 4064 P960030/SI 0 4090 and 4091 P960013/S 15 Locator Plus…	Abbott Medical	1998	—
*	P960013	Tendril DX Model 1388T & 1388K Endocardial Pacing Leads Summary page 1 …let Model Approved with PMA Number 4060, 4062 and 4064 P960030/SI 0 4090 and 4091 P960013/S 15 Locator Plus P960013/S022 S-60-S,S-60-X,S-60-F…	Abbott Medical	1997	—
*	P030054	ST Jude Medical Epic HF System Summary page 5 …stylet kit models 4090 and 4091 through this 51 OK Pre- Market Notification. 3) Stylet Model 4078S A. Device Description Stylet kit 4078S was approved under PMA P030054/S49 with Quickflex Model 1156T and Quickflex XL Model 1158T on July 25, 2007. The Quickflex Model 1156T and Quickflex XL…	Abbott Medical	2004	35
*	P950022	TVL (TM) Lead System Summary page 1 …4090 and 4091 P960013/S 15 Locator Plus P960013/S022 S-60-S,S-60-X,S-60-F P950022/S 16 S-65-S, S-65-F, S-65-X P950022/S14, P950022/SI6 S-75-X, S-75-S…	Abbott Medical	1996	Class I

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K191469	Biotronik Stylets	Biotronik, Inc.	2019	0

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.

P950022TVL (TM) Lead SystemAbbott Medical · 1996 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K191469 (Biotronik, Inc., 2019) 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. 2009, this device’s year, is highlighted.

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	—	—

What is it indicated for?

The stylet is intended to aid in the placement of St. Jude Medical transvenous leads.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090163: Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090163

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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