510(k) · Cleared
Recalled · Class II · 2021GORE Molding and Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore and Associates, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jan 31, 2018 as substantially equivalent to K120381 (Qxmedical, LLC, 2012) after a 159-day review. Its family tree reaches back 5 generations to 2001. It has been recalled once.
- Decided
- Jan 31, 2018
- Review
- 159 days
- Class
- Class II
- Product code
- MJN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003495 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 4 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 3 generations backK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
- 2 generations backK091624 Stent Graft Balloon CatheterVia Biomedical, Inc. · 2009
- 1 generation backK120381 Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 2012
- This deviceK172567 GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −4 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −3 | K050038 | Reliant Stent Graft Balloon Catheter | Medtronic Endovascular Innovations | 2005 | — |
| −2 | K091624 | Stent Graft Balloon Catheter | Via Biomedical, Inc. | 2009 | — |
| −1 | K120381 | Q50 Plus Stent Graft Balloon Catheter | Qxmedical, LLC | 2012 | — |
| 0 (this device) | K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 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.
Planning a device in MJN? 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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 |
|---|---|---|---|
| * | K120381 | Q50 Plus Stent Graft Balloon CatheterSummary page 4…Class II Predicate Devices Device Name 510(k) Number QXMédical, Q50® PLUS Stent Graft Balloon K120381 Catheter This predicate device has not been subject to a design-related recall. K172567 510(k… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2021 | Class II | Z-2340-2021 | Process change control | Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K120381.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GORE Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses (stent grafts).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172567: GORE Molding and Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172567
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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