510(k) · Cleared
ClearedOcclusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embolx, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on May 31, 2015 as substantially equivalent to K103780 (Micrus Endovascular Corporation, 2011) after a 251-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- May 31, 2015
- Review
- 251 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960806 (1996). 15 ancestors in all, the oldest K781772 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 5 generations backK032624 Micrus MicrocatheterMicrus Corp. · 2003
- 4 generations backK060116 Micrus Courier MicrocathetersMicrus Endovascular Corporation · 2006
- 3 generations backK080861 Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008
- 2 generations backK091504 Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit…Micrus Endovascular Corporation · 2009
- 1 generation backK103780 Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent…Micrus Endovascular Corporation · 2011
- This deviceK142692 Occlusion Balloon CatheterEmbolx, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK180904 Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −5 | K032624 | Micrus Microcatheter | Micrus Corp. | 2003 | — |
| −4 | K060116 | Micrus Courier Microcatheters | Micrus Endovascular Corporation | 2006 | — |
| −3 | K080861 | Micrus Ascent Occlusion Balloon Catheter | Micrus Endovascular Corporation | 2008 | — |
| −2 | K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion… | Micrus Endovascular Corporation | 2009 | — |
| −1 | K103780 | Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion… | Micrus Endovascular Corporation | 2011 | — |
| 0 (this device) | K142692 | Occlusion Balloon Catheter | Embolx, Inc. | 2015 | — |
| +1 | K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K103780 | Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Summary page 4…ular (a division of Johnson & Johnson Medical Ltd) Predicate Device Common Name: Catheter, Intravascular Occluding, Temporary Predicate Device Premarket Notification # K103780 Predicate Device Classification: 21 CFR 870.4450 Predicate Device Classification & Class II, Product Code: MIN B. Date Summar… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180904 | Sniper Infusion Catheter with Balloon Occlusion | 2018 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K180904 (Embolx, Inc., 2018) has gone furthest, with 0 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. 2015, 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 Embolx Occlusion Balloon Catheter is intended for use in the blood vessels of the peripheral vasculature where
temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion for selectively
stopping or controlling blood flow. The Embolx Occlusion Balloon Catheter is also intended to assist in the delivery of
diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142692: 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/K142692
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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