510(k) · Cleared
ClearedScepter XC 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 Jan 13, 2012 as substantially equivalent to K110741 (MicroVention, Inc., 2011) after a 28-day review. Its family tree reaches back 4 generations to 2001. 3 later devices descend from it.
- Decided
- Jan 13, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011526 (2001). 7 ancestors in all, the oldest K001237 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK011526 Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121…Micro Therapeutics, Inc. · 2001
- 3 generations backK090728 Hyperglide Occlusion Balloon SystemEv3, Inc. · 2009
- 2 generations backK091458 Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon…Ev3 Neurovascular · 2009
- 1 generation backK110741 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011
- This deviceK113698 Scepter XC Occlusion Balloon CatheterMicroVention, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK121785 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK182829 Scepter Mini Occlusion Balloon CatheterMicroVention, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK183045 Eclipse 2LBalt USA, LLC · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129… | Micro Therapeutics, Inc. | 2001 | — |
| −3 | K090728 | Hyperglide Occlusion Balloon System | Ev3, Inc. | 2009 | — |
| −2 | K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model… | Ev3 Neurovascular | 2009 | — |
| −1 | K110741 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2011 | — |
| 0 (this device) | K113698 | Scepter XC Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| +1 | K121785 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| +1 | K182829 | Scepter Mini Occlusion Balloon Catheter | MicroVention, Inc. | 2019 | — |
| +2 | K183045 | Eclipse 2L | Balt USA, LLC | 2019 | — |
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 |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K110741 | Scepter C Occlusion Balloon CatheterSummary page 1…Naomi Gong Date Prepared: December 15, 2011 Predicate Device: ,Number ,-Description L NS Clearance Date. KI 110741 MicroVention Scepter C Occlusion September 29, 2011 Balloon Catheter Device D… | 2011 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K121785 (MicroVention, Inc., 2012) has gone furthest, with 2 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?
The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113698: Scepter XC 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/K113698
Report an extraction error
Are you the manufacturer?
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