510(k) · Cleared

Cleared

Solopath Balloon Expandable Transfemoral Introducer

K092014510(k) TraditionalCleared Oct 8, 200994-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

Onset Medical Corporation · DYB Introducer, Catheter

Cleared on Oct 8, 2009 after a 94-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.

Decided: Oct 8, 2009
Review: 94 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 0

12 later devices descend from it, 2 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.

This deviceK092014 Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2009
Descendant · cites it directly · 11 of its ownK100819 The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · Recalled (Class I)
Descendant · 2 generations on · 4 of its ownK152225 Edwards eSheath Introducer SetEdwards Lifesciences · 2015
Descendant · 3 generations on · 3 of its ownK162184 Edwards eSheath Introducer SetEdward Lifesciences · 2016
Descendant · 3 generations on · 2 of its ownK200258 Edwards eSheath Introducer SetEdwards Lifesciences · 2020
Descendant · 4 generations on · 1 of its ownK244046 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010high 3 (2016) · low 0 (2011)2026

Class I recalls in this family

K100819 The Solopath Balloon Expandable Transfemoral…cites it directly · 2010
K152498 SoloPath Re-Collapsible Access System2 generations on · 2016
K181817 transGlideXT Expandable Introducer3 generations on · 2019

Most influential descendants

Showing 5 of 12 · See all

K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · cites it directly11descendants
K152225Edwards eSheath Introducer SetEdwards Lifesciences · 2015 · 2 generations on4descendants
K162184Edwards eSheath Introducer SetEdward Lifesciences · 2016 · 3 generations on3descendants
K200258Edwards eSheath Introducer SetEdwards Lifesciences · 2020 · 3 generations on2descendants
K244046Edwards eSheath Optima introducer setEdwards Lifesciences · 2025 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K092014	Solopath Balloon Expandable Transfemoral Introducer	Onset Medical Corporation	2009	—
+1	K100819	The Solopath Balloon Expandable Transfemoral Introducer	Onset Medical Corporation	2010	Class I
+2	K152225	Edwards eSheath Introducer Set	Edwards Lifesciences	2015	—
+3	K162184	Edwards eSheath Introducer Set	Edward Lifesciences	2016	—
+3	K200258	Edwards eSheath Introducer Set	Edwards Lifesciences	2020	—
+4	K244046	Edwards eSheath Optima introducer set	Edwards Lifesciences	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	1
2013	1	0
2014	1	0
2015	2	0
2016	3	1
2019	1	1
2020	1	0
2025	2	0

FIG. 1 — Lineage of K092014, 2009–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have 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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100819	The Solopath Balloon Expandable Transfemoral Introducer Class I	Onset Medical Corporation	2010	11
K121404	Solopath RE-Collapsible Access System	Onset Medical Corporation	2013	1

Has anything in its family been recalled? (3 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.

K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
K181817transGlideXT Expandable IntroducerTransaortic Medical, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K100819 (Onset Medical Corporation, 2010) has gone furthest, with 11 descendants of its own.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SoloPathTM Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K092014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092014: Solopath Balloon Expandable Transfemoral Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092014

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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