510(k) · Cleared
Recalled · Class I · 2019SoloPath Re-Collapsible Access System
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 Jan 5, 2016 as substantially equivalent to K121404 (Onset Medical Corporation, 2013) after a 126-day review. Its family tree reaches back 4 generations to 2003. 2 of the 8 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jan 5, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032073 (2003). 7 ancestors in all, the oldest K013282 (2001). No later device cites it as a predicate yet. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 3 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 2 generations backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- 1 generation backK121404 Solopath RE-Collapsible Access SystemOnset Medical Corporation · 2013
- This deviceK152498 SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016
Class I recalls in this family
- K100819 The Solopath Balloon Expandable Transfemoral…2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −2 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| −1 | K121404 | Solopath RE-Collapsible Access System | Onset Medical Corporation | 2013 | — |
| 0 (this device) | K152498 | SoloPath Re-Collapsible Access System | Onset Medical Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
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
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 |
|---|---|---|---|
| * | K121404 | Solopath RE-Collapsible Access SystemSummary page 6…tion: Class II C. PREDICATE DEVICE (807.92(a)(3)) Substantial equivalence is claimed to the following legally marketed device: x K121404 SoloPath Re-Collapsible Access System, manufactured by Onset Medical, California (a division of Terumo Medica… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2019 | Class I | Z-1375-2019 | 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. |
| Apr 26, 2019 | Class I | Z-1376-2019 | 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.
- K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 7 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 SoloPath® Re-Collapsible Access System is indicated for percutaneous insertion into the femoral artery over a guidewire and,
once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery. The device may also be used to
expand femoroiliac artery lesions to facilitate its use as an Access System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152498: 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/K152498
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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