510(k) · Cleared
ClearedBridge 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 Dec 23, 2020 as substantially equivalent to K153530 (Spectranetics, Inc., 2016) after a 20-day review. Its family tree reaches back 3 generations to 2002. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 23, 2020
- Review
- 20 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021721 (2002). No later device cites it as a predicate yet. 1 of the 4 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 deviceK203540 Bridge Occlusion BalloonSpectranetics, Inc. · 2020
Class I recalls in this family
- K153530 Bridge Occlusion Balloondirect predicate · 2016
View 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) | K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2020 | — |
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…al Model Numbers: 590-001 Predicate Device The subject device (Bridge Occlusion Balloon) was compared to the following legally marketed predicate device: 510(k) Number: K153530 Manufacturer: Spectranetics Trade Name: Bridge Occlusion Balloon Device Common Name: Catheter, Intravascular Occluding, Temporary… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2020, 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/K203540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203540: Bridge Occlusion Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203540
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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