510(k) · Cleared
ClearedEquinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo
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 May 18, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- May 18, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK001237 Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM…Micro Therapeutics, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK091458 Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon…Ev3 Neurovascular · 2009
- Descendant · 2 generations on · 4 of its ownK110741 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK113698 Scepter XC Occlusion Balloon CatheterMicroVention, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK121785 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK100063 Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon…Ev3, Inc. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K091458Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112…Ev3 Neurovascular · 2009 · cites it directly8descendants
- K110741Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011 · 2 generations on4descendants
- K113698Scepter XC Occlusion Balloon CatheterMicroVention, Inc. · 2012 · 3 generations on3descendants
- K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2012 · 3 generations on2descendants
- K100063Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…Ev3, Inc. · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001237 | Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15… | Micro Therapeutics, Inc. | 2000 | — |
| +1 | K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model… | Ev3 Neurovascular | 2009 | — |
| +2 | K110741 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2011 | — |
| +3 | K113698 | Scepter XC Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| +3 | K121785 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| +2 | K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter… | Ev3, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2019 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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?
- 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 | — |
https://510kreport.com/device/K001237 · printed Nov 3, 2026
Cite this page
510(k) Report. “K001237: Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15 MM Balloon, 4 & 13 MM Tip), (20 MM Balloo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001237
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026