510(k) · Cleared
ClearedHyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104
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 Oct 15, 2009 as substantially equivalent to K001237 (Micro Therapeutics, Inc., 2000) and 3 other predicates after a 150-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it.
- Decided
- Oct 15, 2009
- Review
- 150 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K011526 (2001). 5 ancestors in all, the oldest K001237 (2000). 8 later devices descend from it, 3 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 deviceK091458 Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon…Ev3 Neurovascular · 2009
- Descendant · cites it directly · 4 of its ownK110741 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK113698 Scepter XC Occlusion Balloon CatheterMicroVention, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK121785 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2012
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K110741Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011 · cites it directly4descendants
- K113698Scepter XC Occlusion Balloon CatheterMicroVention, Inc. · 2012 · 2 generations on3descendants
- K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2012 · 2 generations on2descendants
- 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
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) | K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model… | Ev3 Neurovascular | 2009 | — |
| +1 | K110741 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2011 | — |
| +2 | K113698 | Scepter XC Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| +2 | K121785 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K001237 | Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM… | 2000 |
| * | K011656 | Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771 | 2001 |
| * | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126…Summary page 2…as a system, which includes the required 0.010" guidewire. This description has not changed from the predicate device (KO011526, K090728). Performance data No bench testing and biocompatibility testing was performed to… | 2001 |
| * | K090728 | Hyperglide Occlusion Balloon SystemSummary page 1…KOO 123 7), HyperForm Occlusion Balloon Catheter (KOI 1656), and HyperGlide Occlusion Balloon Catheter (KOI 1526, K090728). Intended use The MTI HyperFormT M Occlusion Balloon Catheters are indicated for use… | 2009 |
What descends from it? (8)
3 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 5 ancestors has a recall.
- Of its descendants, K110741 (MicroVention, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K001237.
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 MTI HyperFormTM Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms. The MTI HyperGlideTM Occlusion Balloon Catheters are indicated for…
Read the full statement (108 words)
The MTI HyperFormTM Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.
The MTI HyperGlideTM Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091458 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091458
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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