510(k) · Cleared

Cleared

Talon Transseptal Sheath

K231108510(k) TraditionalCleared Sep 27, 2023161-day reviewClass II21 CFR 870.1340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inari Medical, Inc. · DYB Introducer, Catheter

Cleared on Sep 27, 2023 as substantially equivalent to K183655 (Baylis Medical Company, Inc., 2019) after a 161-day review. Its family tree reaches back 3 generations to 2002. 1 of the 4 devices in its family, counting itself, has a Class I recall.

Decided: Sep 27, 2023
Review: 161 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K013919 (2002). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002 · Recalled
2 generations backK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Recalled (Class I)
1 generation backK183655 VersaCross Transseptal SheathBaylis Medical Company, Inc. · 2019 · Recalled
This deviceK231108 Talon Transseptal SheathInari Medical, Inc. · 2023

Class I recalls in this family

K102948 Torflex Transseptal Guiding Sheath2 generations back · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K013919	Torflex Transseptal Guiding Sheath	Baylis Medical Co., Inc.	2002	1
−2	K102948	Torflex Transseptal Guiding Sheath	Baylis Medical Co., Inc.	2011	Class I
−1	K183655	VersaCross Transseptal Sheath	Baylis Medical Company, Inc.	2019	3
0 (this device)	K231108	Talon Transseptal Sheath	Inari Medical, Inc.	2023	—

FIG. 1 — Lineage of K231108, 2002–2023Source: 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 DYB device

#1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K183655	VersaCross Transseptal Sheath Summary page 4 …sification number 21 CFR 870.1340 Product code DYB Regulatory class II Predicate device(s) Baylis Medical, VersaCross Transseptal Sheath (K183655) Reference device(s) Cook, Extra Large Check-Flo Introducer (K203670) Inari Medical, Triever24 (K…	Baylis Medical Company, Inc.	2019	3
†	K203670	Extra Large Check-Flo Introducer	Cook Incorporated	2021	—
†	K213402	Triever24, Triever20	Inari Medical	2022	—

Also cleared against K183655: 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.

K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
1 other device also cites its predicate K183655.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

The Talon Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation/puncture.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231108 · printed Nov 5, 2026

Cite this page

510(k) Report. “K231108: Talon Transseptal Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231108

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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