510(k) · Cleared
ClearedEqualizer Occlusion Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jul 22, 2014 as substantially equivalent to K021721 (Boston Scientific Corp, 2002) after a 169-day review. Its family tree reaches back 1 generation to 2002. 1 of the 19 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Jul 22, 2014
- Review
- 169 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021721 (2002). 17 later devices descend from it, 3 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK021721 Equalizer Balloon CatheterBoston Scientific Corp · 2002 · Recalled
- This deviceK140273 Equalizer Occlusion Balloon CatheterBoston Scientific Corp · 2014
- Descendant · cites it directly · 8 of its ownK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK172790 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK153530 Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK183679 Occlusion Balloon CatheterQxmedical, LLC · 2019
- Descendant · cites it directly · 2 of its ownK160067 RenovoCathRenovorx, Inc. · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153530 Bridge Occlusion Ballooncites it directly · 2016
Most influential descendants
Showing 5 of 17 · See all- K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · cites it directly8descendants
- K172790ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 2 generations on4descendants
- K153530Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · cites it directly4descendants
- K183679Occlusion Balloon CatheterQxmedical, LLC · 2019 · 2 generations on2descendants
- K160067RenovoCathRenovorx, Inc. · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021721 | Equalizer Balloon Catheter | Boston Scientific Corp | 2002 | 4 |
| 0 (this device) | K140273 | Equalizer Occlusion Balloon Catheter | Boston Scientific Corp | 2014 | — |
| +1 | K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +2 | K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +1 | K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016 | Class I |
| +2 | K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019 | — |
| +1 | K160067 | RenovoCath | Renovorx, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 1 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K021721 | Equalizer Balloon CatheterSummary page 1…heter, Intravascular Occluding, Temporary Classification Class 11, 21 CFR Part 870.4450 -Vascular Clamp Predicate Equalizer m Occlusion Balloon Catheter K021721 20 June 2002 Device(s) _____________________________ ____ Device… | 2002 |
What descends from it? (17)
See all 173 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 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Equalizer"' Occlusion Balloon Catheter isIndicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
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/K140273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140273: Equalizer 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/K140273
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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