510(k) · Cleared
ClearedScepter Mini Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · DQY Catheter, Percutaneous
Cleared on Jul 10, 2019 as substantially equivalent to K110741 (MicroVention, Inc., 2011) and 2 other predicates after a 278-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jul 10, 2019
- Review
- 278 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K011526 (2001). 14 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK011526 Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121…Micro Therapeutics, Inc. · 2001
- 5 generations backK090728 Hyperglide Occlusion Balloon SystemEv3, Inc. · 2009
- 4 generations backK091458 Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon…Ev3 Neurovascular · 2009
- 3 generations backK110741 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2011
- 2 generations backK113698 Scepter XC Occlusion Balloon CatheterMicroVention, Inc. · 2012
- 1 generation backK121785 Scepter C Occlusion Balloon CatheterMicroVention, Inc. · 2012
- This deviceK182829 Scepter Mini Occlusion Balloon CatheterMicroVention, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129… | Micro Therapeutics, Inc. | 2001 | — |
| −5 | K090728 | Hyperglide Occlusion Balloon System | Ev3, Inc. | 2009 | — |
| −4 | K091458 | Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model… | Ev3 Neurovascular | 2009 | — |
| −3 | K110741 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2011 | — |
| −2 | K113698 | Scepter XC Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| −1 | K121785 | Scepter C Occlusion Balloon Catheter | MicroVention, Inc. | 2012 | — |
| 0 (this device) | K182829 | Scepter Mini Occlusion Balloon Catheter | MicroVention, Inc. | 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 |
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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 4…on.com (714) 247-8296 Date: October 4, 2018 Predicate Device: Scepter C Occlusion Balloon Catheter (K110741, K121785) Scepter XC Occlusion Balloon Catheter (K113698, K121785) Reference Device:… | 2011 |
| * | K121785 | Scepter C Occlusion Balloon CatheterSummary page 4…(714) 247-8296 Date: October 4, 2018 Predicate Device: Scepter C Occlusion Balloon Catheter (K110741, K121785) Scepter XC Occlusion Balloon Catheter (K113698, K121785) Reference Device: Headway… | 2012 |
| * | K113698 | Scepter XC Occlusion Balloon CatheterSummary page 4…er 4, 2018 Predicate Device: Scepter C Occlusion Balloon Catheter (K110741, K121785) Scepter XC Occlusion Balloon Catheter (K113698, K121785) Reference Device: Headway 17 Microcatheter (K083343) Device Description: Scepter Mini Occlusion Balloon… | 2012 |
| † | K083343 | Headway 17 Microcatheter | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 2 other devices also cite its predicate K110741.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Scepter Mini Occlusion Balloon Catheter is intended: For use in the peripheral and neuro vasculature 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. For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast…
Read the full statement (133 words)
The Scepter Mini Occlusion Balloon Catheter is intended:
For use in the peripheral and neuro vasculature 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.
For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182829: Scepter Mini 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/K182829
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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