510(k) · Cleared
Recalled · Class I · 2019The Solopath Balloon Expandable Transfemoral Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onset Medical Corporation · DYB Introducer, Catheter
Cleared on Aug 2, 2010 as substantially equivalent to K092014 (Onset Medical Corporation, 2009) after a 132-day review. Its family tree reaches back 1 generation to 2009. 3 of the 13 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Aug 2, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092014 (2009). 11 later devices descend from it, 4 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK092014 Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2009
- This deviceK100819 The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010
- Descendant · cites it directly · 4 of its ownK152225 Edwards eSheath Introducer SetEdwards Lifesciences · 2015
- Descendant · 2 generations on · 3 of its ownK162184 Edwards eSheath Introducer SetEdward Lifesciences · 2016
- Descendant · 2 generations on · 2 of its ownK200258 Edwards eSheath Introducer SetEdwards Lifesciences · 2020
- Descendant · 3 generations on · 1 of its ownK244046 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025
- Descendant · cites it directly · 1 of its ownK152194 transGlide Expandable IntroducerTransaortic Medical, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K152225Edwards eSheath Introducer SetEdwards Lifesciences · 2015 · cites it directly4descendants
- K162184Edwards eSheath Introducer SetEdward Lifesciences · 2016 · 2 generations on3descendants
- K200258Edwards eSheath Introducer SetEdwards Lifesciences · 2020 · 2 generations on2descendants
- K244046Edwards eSheath Optima introducer setEdwards Lifesciences · 2025 · 3 generations on1descendant
- K152194transGlide Expandable IntroducerTransaortic Medical, Inc. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092014 | Solopath Balloon Expandable Transfemoral Introducer | Onset Medical Corporation | 2009 | — |
| 0 (this device) | K100819 | The Solopath Balloon Expandable Transfemoral Introducer | Onset Medical Corporation | 2010 | — |
| +1 | K152225 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2015 | — |
| +2 | K162184 | Edwards eSheath Introducer Set | Edward Lifesciences | 2016 | — |
| +2 | K200258 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2020 | — |
| +3 | K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025 | — |
| +1 | K152194 | transGlide Expandable Introducer | Transaortic Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
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.
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
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 | Decided |
|---|---|---|---|
| * | K092014 | Solopath Balloon Expandable Transfemoral IntroducerSummary page 1…of Predicate Device The predicate device is the SoloPath~" Balloon Expandable TransFemoral Introducer, that was cleared for commercial distribution under 510(k) K092014. 6.4 Device Description The SoloPathTm Balloon Expandable TransFemoral Introducer is an intravascular catheter in… | 2009 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2019 | Class I | Z-1374-2019 | Device Design | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. |
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.
- 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 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 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 for devices introduced into the femoral iliac arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100819 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100819: The Solopath Balloon Expandable Transfemoral Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100819
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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