510(k) · Cleared
ClearedHyperglide Occlusion Balloon System, Model 104-4310, 104-4315
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3 Neurovascular · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Sep 22, 2009 as substantially equivalent to K011526 (Micro Therapeutics, Inc., 2001) and 2 other predicates after a 39-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 22, 2009
- Review
- 39 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011526 (2001). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011526 Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121…Micro Therapeutics, Inc. · 2001
- 1 generation backK090728 Hyperglide Occlusion Balloon SystemEv3, Inc. · 2009
- This deviceK092495 Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Ev3 Neurovascular · 2009
- Descendant · cites it directly · 2 of its ownK100063 Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon…Ev3, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK101570 Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular · 2010
- Descendant · 2 generations on · 0 of its ownK122576 Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K100063Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…Ev3, Inc. · 2010 · cites it directly2descendants
- K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular · 2010 · cites it directly1descendant
- K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129… | Micro Therapeutics, Inc. | 2001 | — |
| −1 | K090728 | Hyperglide Occlusion Balloon System | Ev3, Inc. | 2009 | — |
| 0 (this device) | K092495 | Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 | Ev3 Neurovascular | 2009 | — |
| +1 | K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter… | Ev3, Inc. | 2010 | — |
| +1 | K101570 | Hyperglide and Hyperform Occlusion Balloon Systems | Micro Therapeutics Dba Ev3 Neurovascular | 2010 | — |
| +2 | K122576 | Transform Occlusion Balloon Catheter (Compliant and Super Compliant | Stryker Neurovascular | 2013 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126…Summary page 1…21 CFR 870.4450 Ill. Predicate Devices Micro Therapeutics HYPERGLIDE Occlusion Balloon System cleared under 510(k) numbers K011526, K021066 and K090728. IV. Device Description The HYPERGLIDE Occlusion Balloon System is a single lumen,… | 2001 |
| * | K021066 | Modification to Hyperglide Occlusion Balloon SystemSummary page 1…CFR 870.4450 Ill. Predicate Devices Micro Therapeutics HYPERGLIDE Occlusion Balloon System cleared under 510(k) numbers K011526, K021066 and K090728. IV. Device Description The HYPERGLIDE Occlusion Balloon System is a single lumen, open-end… | 2002 |
| * | K090728 | Hyperglide Occlusion Balloon SystemSummary page 1…Ill. Predicate Devices Micro Therapeutics HYPERGLIDE Occlusion Balloon System cleared under 510(k) numbers K011526, K021066 and K090728. IV. Device Description The HYPERGLIDE Occlusion Balloon System is a single lumen, open-ended balloon… | 2009 |
What descends from it? (3)
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100063 (Ev3, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K011526.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 HYPERGLIDE Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HYPERGLIDE Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092495 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092495
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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