510(k) · Cleared
ClearedFogarty Occlusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Nov 23, 2015 as substantially equivalent to K093911 (Edwards Lifesciences, LLC, 2010) after a 60-day review. Its family tree reaches back 1 generation to 2010. 2 later devices descend from it.
- Decided
- Nov 23, 2015
- Review
- 60 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093911 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK093911 Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2010
- This deviceK152762 Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2015
- Descendant · cites it directly · 0 of its ownK211610 Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2022
- Descendant · cites it directly · 0 of its ownK160598 REBOA Balloon CatheterNuMED, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093911 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2010 | — |
| 0 (this device) | K152762 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2015 | — |
| +1 | K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2022 | — |
| +1 | K160598 | REBOA Balloon Catheter | NuMED, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K093911 | Fogarty Occlusion CatheterSummary page 4…CFR 870.4450) Predicate Device(s): Fogarty Occlusion Catheter, Pre-amendment device Fogarty Occlusion Catheter, K093911 (SE, 21January 2010) Device Description: The Fogarty Occlusion Catheters are indicated for temporary… | 2010 |
| * | — | Fogarty Occlusion Catheter, Pre-amendment device Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.
The Large Occlusion catheters are intended to be used for temporary occlusion in the aorta, vena cava, and internal jugular vein.
The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152762: Fogarty Occlusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152762
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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