510(k) · Cleared
ClearedScepter C Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Aug 10, 2012 as substantially equivalent to K110741 (MicroVention, Inc., 2011) and 2 other predicates after a 53-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 10, 2012
- Review
- 53 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K011526 (2001). 13 ancestors in all, the oldest K925813 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK011526 Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121…Micro Therapeutics, Inc. · 2001
- 4 generations backK090728 Hyperglide Occlusion Balloon SystemEv3, Inc. · 2009
- 3 generations backK091458 Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon…Ev3 Neurovascular · 2009
- 2 generations backK110741 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011
- 1 generation backK113698 Scepter XC Occlusion Balloon CatheterMicroVention, Inc. · 2012
- This deviceK121785 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK182829 Scepter Mini Occlusion Balloon CatheterMicroVention, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK183045 Eclipse 2LBalt USA, LLC · 2019
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 |
|---|---|---|---|---|---|
| −5 | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129… | Micro Therapeutics, Inc. | 2001 | — |
| −4 | K090728 | Hyperglide Occlusion Balloon System | Ev3, Inc. | 2009 | — |
| −3 | K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model… | Ev3 Neurovascular | 2009 | — |
| −2 | K110741 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2011 | — |
| −1 | K113698 | Scepter XC Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| 0 (this device) | K121785 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| +1 | K182829 | Scepter Mini Occlusion Balloon Catheter | MicroVention, Inc. | 2019 | — |
| +1 | K183045 | Eclipse 2L | Balt USA, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K110741 | Scepter C Occlusion Balloon CatheterSummary page 1…June 15, 2012 Contact: Naomi Gong Predicate Device: 51 0(k) Nu in ber Description Clearance Date KI 110741 Scepter C Occlusion Balloon Catheter Sep 29, 2011 KI 13698 Scepter XC Occlusion B… | 2011 |
| * | K113698 | Scepter XC Occlusion Balloon CatheterSummary page 3…e Device Predicate Device 510(k) Subject Device Scepter C/XC Headway 17 ____________ (KI 10741/1(113698) (K083343) _ _______________ Intended Use For use inthe blood vessels For general… | 2012 |
| * | K083343 | Headway 17 MicrocatheterSummary page 1…Scepter C Occlusion Balloon Catheter Sep 29, 2011 KI 13698 Scepter XC Occlusion Balloon Catheter Jan 13, 2012 K083343 Headway 17 Microcatheter Dec 4, 2008 Device Description: The Scepter C and XC Occlu… | 2008 |
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?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K182829 (MicroVention, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110741.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms. For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as…
Read the full statement (112 words)
For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.
For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.
For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121785: Scepter C Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121785
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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