510(k) · Cleared
ClearedEclipse 2L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balt USA, LLC · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Apr 30, 2019 as substantially equivalent to K121785 (MicroVention, Inc., 2012) after a 179-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Apr 30, 2019
- Review
- 179 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
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 deviceK183045 Eclipse 2LBalt USA, LLC · 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) | 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 |
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 |
|---|---|---|---|
| * | K121785 | Scepter C Occlusion Balloon CatheterSummary page 4…cal and Physical Medicine Devices (Office of Device Evaluation, CDRH) PREDICATE DEVICE [807.92(a)(3)] Scepter C/XC Occlusion Balloon Catheter (K121785) REFERENCE DEVICE HyperGlide and HyperForm Occlusion Balloons (K101570) Page 1 =… | 2012 |
| † | K101570 | Hyperglide and Hyperform Occlusion Balloon Systems | 2010 |
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 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K121785.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 ECLIPSE 2L is indicated 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. ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as…
Read the full statement (123 words)
The ECLIPSE 2L is indicated 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.
ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.
ECLIPSE 2L is also indicated for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as DMSO based embolization materials, that have been approved for use in the neurovasculature and are compatible with the diameter of the ECLIPSE 2L.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183045: Eclipse 2L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183045
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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