510(k) · Cleared

Cleared

Mond Rvot Stylet Models 4140, 4141, 4150, 4151

K080924510(k) TraditionalCleared Apr 30, 200828-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

St. Jude Medical, Cardiac Rhythm Management Divisi · DRB Stylet, Catheter

Cleared on Apr 30, 2008 as substantially equivalent to P960013 (Abbott Medical, 1997) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1996. 1 of the 3 devices in its family, counting itself, has a Class I recall.

Decided: Apr 30, 2008
Review: 28 days
Class: Class II
Product code: DRB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to P950022 (1996). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 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 deviceK080924 Mond Rvot Stylet Models 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi · 2008

Class I recalls in this family

P950022 TVL (TM) Lead Systemdirect predicate · 1996

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)	K080924	Mond Rvot Stylet Models 4140, 4141, 4150, 4151	St. Jude Medical, Cardiac Rhythm Management Divisi	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K080924, 1996–2008Source: 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? (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	Applicant	Decided	Recalls
*	P960013	Tendril DX Model 1388T & 1388K Endocardial Pacing Leads Summary page 1 …FR 870.1380 Legally marketed device to which your firm is claiming equivalence: St. Jude Medical Model 4090 and 4091 approved under. P960013/S 15 and S-75-X stylets approved under P950022/S17. Device Description: The St Jude Medical (SJM)…	Abbott Medical	1997	—
*	P950022	TVL (TM) Lead System Summary page 1 …nce: St. Jude Medical Model 4090 and 4091 approved under. P960013/S 15 and S-75-X stylets approved under P950022/S17. Device Description: The St Jude Medical (SJM) Mond RVOT Stylet is an accessory implant tool, intended for use in the place…	Abbott Medical	1996	Class I

Also cleared against P960013: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
1 other device also cites its predicate P960013.

How does its category compare?

All DRB devices

DRB Stylet, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 CPS Mond™ RVOT Stylets are indicated for:

The St. Jude Medical Mond™ RVOT Stylet is designed to place St. Jude Medical right ventricular active fixation leads in the right ventricular outflow tract.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080924 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080924: Mond Rvot Stylet Models 4140, 4141, 4150, 4151.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080924

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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