510(k) · Cleared
ClearedHyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jun 20, 2001 after a 22-day review. The FDA summary names its predicate without a number. 2 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.
- Decided
- Jun 20, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 5 citing it directly. 2 of the 22 devices in this family, counting this one, have a Class I recall.
- This deviceK011656 Hyperform Occlusion Balloon System, Model 104-4470, 104-4471…Micro Therapeutics, Inc. · 2001
- Descendant · cites it directly · 8 of its ownK091458 Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon…Ev3 Neurovascular · 2009
- Descendant · cites it directly · 6 of its ownK021210 Arteria Occlusion BalloonArteria Medical Science, Inc. · 2002
- Descendant · 2 generations on · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK110741 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK080861 Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K091458Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112…Ev3 Neurovascular · 2009 · cites it directly8descendants
- K021210Arteria Occlusion BalloonArteria Medical Science, Inc. · 2002 · cites it directly6descendants
- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · 2 generations on5descendants
- K110741Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011 · 2 generations on4descendants
- K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011656 | Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771 | Micro Therapeutics, Inc. | 2001 | — |
| +1 | K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model… | Ev3 Neurovascular | 2009 | — |
| +1 | K021210 | Arteria Occlusion Balloon | Arteria Medical Science, Inc. | 2002 | — |
| +2 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +2 | K110741 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2011 | — |
| +1 | K080861 | Micrus Ascent Occlusion Balloon Catheter | Micrus Endovascular Corporation | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | — | MTI Equinox™ Occlusion Balloon Catheter Named without a submission number |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112… | 2009 | 8 |
| K021210 | Arteria Occlusion Balloon | 2002 | 6 |
| K080861 | Micrus Ascent Occlusion Balloon Catheter | 2008 | 4 |
| K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide… | 2010 | 2 |
| K101570 | Hyperglide and Hyperform Occlusion Balloon Systems | 2010 | 1 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K091458 (Ev3 Neurovascular, 2009) has gone furthest, with 8 descendants of its own.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 HyperForm™ Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI HyperForm™ Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011656 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011656: Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011656
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026