510(k) · Cleared
ClearedOcclusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qxmedical, LLC · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Apr 24, 2019 as substantially equivalent to K153530 (Spectranetics, Inc., 2016) after a 117-day review. Its family tree reaches back 3 generations to 2002. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Apr 24, 2019
- Review
- 117 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021721 (2002). 2 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK021721 Equalizer Balloon CatheterBoston Scientific Corp · 2002 · Recalled
- 2 generations backK140273 Equalizer Occlusion Balloon CatheterBoston Scientific Corp · 2014
- 1 generation backK153530 Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · Recalled (Class I)
- This deviceK183679 Occlusion Balloon CatheterQxmedical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK251358 Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices · 2025
- Descendant · cites it directly · 0 of its ownK210602 AortaSTAT Occlusion DeviceRenalpro Medical, Inc. · 2021
Class I recalls in this family
- K153530 Bridge Occlusion Balloondirect predicate · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021721 | Equalizer Balloon Catheter | Boston Scientific Corp | 2002 | 4 |
| −2 | K140273 | Equalizer Occlusion Balloon Catheter | Boston Scientific Corp | 2014 | — |
| −1 | K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016 | Class I |
| 0 (this device) | K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019 | — |
| +1 | K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | 2025 | — |
| +1 | K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K153530 | Bridge Occlusion BalloonSummary page 4…ct. Predicate Device: Predicate Device Manufacturer 510(k) Status Bridge Occlusion Balloon Spectranetics, Inc. K153530 Reference Device: Reference Device Manufacturer 510(k) Status Stent Graft Balloon Cathe… | 2016 |
| † | K120381 | Q50 Plus Stent Graft Balloon Catheter | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153530Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251358 (Philips Image Guided Therapy Devices, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K153530.
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 Occlusion Balloon Catheter is indicated for temporary occlusion of large vessels, including the superior vena cava, in applications including perioperative occlusion and emergency control of hemorrhage.
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/K183679 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183679: Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183679
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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