510(k) · Cleared

Cleared

Solopath RE-Collapsible Access System

K121404510(k) TraditionalCleared May 3, 2013358-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 May 3, 2013 as substantially equivalent to K092014 (Onset Medical Corporation, 2009) and 2 other predicates after a 358-day review. Its family tree reaches back 3 generations to 2003. 2 of the 8 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: May 3, 2013
Review: 358 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K032073 (2003). 6 ancestors in all, the oldest K013282 (2001). 1 later device descends from it, 1 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
2 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
1 generation backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
This deviceK121404 Solopath RE-Collapsible Access SystemOnset Medical Corporation · 2013
Descendant · cites it directly · 0 of its ownK152498 SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016 · Recalled (Class I)

Class I recalls in this family

K100819 The Solopath Balloon Expandable Transfemoral…direct predicate · 2010
K152498 SoloPath Re-Collapsible Access Systemcites it directly · 2016

Most influential descendants

Showing 1 of 1 · See all

K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K032073	Gore Introducer Sheath with Silicone Pinch Valve	W. L. Gore & Associates, Inc.	2003	—
−2	K082356	Gore Introducer Sheath with Silicone Pinch Valve	W. L. Gore & Associates, Inc.	2008	—
−1	K093791	Gore Dryseal Sheath	W. L. Gore & Associates, Inc.	2010	—
0 (this device)	K121404	Solopath RE-Collapsible Access System	Onset Medical Corporation	2013	—
+1	K152498	SoloPath Re-Collapsible Access System	Onset Medical Corporation	2016	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2009	1	0
2010	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	1

FIG. 1 — Lineage of K121404, 2003–2016Source: 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.

2 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

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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
*	K092014	Solopath Balloon Expandable Transfemoral Introducer Summary page 1 …Catheter Introducer Predicate Devices - Onset Medical SoloPath® Balloon Expandable TransFemoral Introducer (K092014 and K100819) * GORE® DrySeal Sheath (K(093791) * Cook® Extr…	Onset Medical Corporation	2009	—
*	K100819	The Solopath Balloon Expandable Transfemoral Introducer Summary page 1 …er Introducer Predicate Devices - Onset Medical SoloPath® Balloon Expandable TransFemoral Introducer (K092014 and K100819) * GORE® DrySeal Sheath (K(093791) * Cook® Extra Large Chec…	Onset Medical Corporation	2010	Class I
*	K093791	Gore Dryseal Sheath Summary page 1 …ath® Balloon Expandable TransFemoral Introducer (K092014 and K100819) * GORE® DrySeal Sheath (K(093791) * Cook® Extra Large Check-FloO Introducer (Pre-Amendment device) Description The SoloPath®…	W. L. Gore & Associates, Inc.	2010	—
*	—	Cook® Extra Large Check-Flo® Introducer Named without a submission number			—

Also cleared against K092014: 1 other device →

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
K152498	SoloPath Re-Collapsible Access System Class I	Onset Medical Corporation	2016	0

Has anything in its family been recalled? (2 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 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K152498 (Onset Medical Corporation, 2016) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K092014.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SoloPath® Re-Collapsible Access System 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 artery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121404 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121404: Solopath RE-Collapsible Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121404

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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