510(k) · Cleared
ClearedSniper Infusion Catheter with Balloon Occlusion
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 Jun 8, 2018 as substantially equivalent to K142692 (Embolx, Inc., 2015) after a 63-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jun 8, 2018
- Review
- 63 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K960806 (1996). 16 ancestors in all, the oldest K781772 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 6 generations backK032624 Micrus MicrocatheterMicrus Corp. · 2003
- 5 generations backK060116 Micrus Courier MicrocathetersMicrus Endovascular Corporation · 2006
- 4 generations backK080861 Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008
- 3 generations backK091504 Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit…Micrus Endovascular Corporation · 2009
- 2 generations backK103780 Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent…Micrus Endovascular Corporation · 2011
- 1 generation backK142692 Occlusion Balloon CatheterEmbolx, Inc. · 2015
- This deviceK180904 Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −6 | K032624 | Micrus Microcatheter | Micrus Corp. | 2003 | — |
| −5 | K060116 | Micrus Courier Microcatheters | Micrus Endovascular Corporation | 2006 | — |
| −4 | K080861 | Micrus Ascent Occlusion Balloon Catheter | Micrus Endovascular Corporation | 2008 | — |
| −3 | K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion… | Micrus Endovascular Corporation | 2009 | — |
| −2 | K103780 | Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion… | Micrus Endovascular Corporation | 2011 | — |
| −1 | K142692 | Occlusion Balloon Catheter | Embolx, Inc. | 2015 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K142692 | Occlusion Balloon CatheterSummary page 4…avascular Occluding, Temporary Classification Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN III. PREDICATE DEVICE Embolx Occlusion Balloon Catheter, K142692 This predicate has not been subject of a design related recall. IV. DEVICE DESCRIPTION The Sniper® Infusion Catheter with Balloo… | 2015 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Sniper Infusion Catheter with Balloon Occlusion is intended for use in the blood vessels of the peripheral vasculature where temporary occlusion is desired and offers vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Sniper Infusion Catheter with Balloon Occlusion 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 as stated in the FDA summary.
https://510kreport.com/device/K180904 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180904: Sniper Infusion Catheter with Balloon Occlusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180904
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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