510(k) · Cleared
Recalled · Class I · 2020Bridge Occlusion Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Feb 5, 2016 as substantially equivalent to K140273 (Boston Scientific Corp, 2014) after a 58-day review. Its family tree reaches back 2 generations to 2002. 1 of the 7 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Feb 5, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- MJN
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021721 (2002). 4 later devices descend from it, 3 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK021721 Equalizer Balloon CatheterBoston Scientific Corp · 2002 · Recalled
- 1 generation backK140273 Equalizer Occlusion Balloon CatheterBoston Scientific Corp · 2014
- This deviceK153530 Bridge Occlusion BalloonSpectranetics, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK183679 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 · 2 generations on · 0 of its ownK210602 AortaSTAT Occlusion DeviceRenalpro Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK203540 Bridge Occlusion BalloonSpectranetics, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K183679Occlusion Balloon CatheterQxmedical, LLC · 2019 · cites it directly2descendants
- K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices · 2025 · cites it directly0descendants
- K210602AortaSTAT Occlusion DeviceRenalpro Medical, Inc. · 2021 · 2 generations on0descendants
- K203540Bridge Occlusion BalloonSpectranetics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021721 | Equalizer Balloon Catheter | Boston Scientific Corp | 2002 | 4 |
| −1 | K140273 | Equalizer Occlusion Balloon Catheter | Boston Scientific Corp | 2014 | — |
| 0 (this device) | K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016 | — |
| +1 | K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019 | — |
| +1 | K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | 2025 | — |
| +2 | K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | 2021 | — |
| +1 | K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K140273 | Equalizer Occlusion Balloon CatheterSummary page 4…mber: 590-001 Predicate Device The Bridge Occlusion Balloon was compared to the following legally marketed predicate device: 510(k) Number: K140273 Manufacturer: Boston Scientific Trade Name: Equalizer Occlusion Balloon Catheter Device Common Name… | 2014 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2020 | Class II | Z-2143-2020 | Labeling design | There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current… |
| Aug 7, 2017 | Class I | Z-3106-2017 | Nonconforming Material/Component | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K183679 (Qxmedical, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K140273.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Any use for procedures other than those indicated in the instructions is not recommended.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153530: Bridge Occlusion Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153530
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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