510(k) · Cleared
Recalled · 2009Equalizer Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQY Catheter, Percutaneous
Cleared on Jun 20, 2002 after a 27-day review. The FDA summary names its predicate without a number. 1 of the 34 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 20, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 4
- Predicates
- 0
33 later devices descend from it, 6 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- This deviceK021721 Equalizer Balloon CatheterBoston Scientific Corp · 2002
- Descendant · cites it directly · 17 of its ownK140273 Equalizer Occlusion Balloon CatheterBoston Scientific Corp · 2014
- Descendant · 2 generations on · 8 of its ownK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK033670 Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2004
- Descendant · 3 generations on · 4 of its ownK172790 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK153530 Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · Recalled (Class I)
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153530 Bridge Occlusion Balloon2 generations on · 2016
Most influential descendants
Showing 5 of 33 · See all- K140273Equalizer Occlusion Balloon CatheterBoston Scientific Corp · 2014 · cites it directly17descendants
- K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 2 generations on8descendants
- K033670Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2004 · cites it directly7descendants
- K172790ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 3 generations on4descendants
- K153530Bridge Occlusion BalloonSpectranetics, Inc. · 2016 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021721 | Equalizer Balloon Catheter | Boston Scientific Corp | 2002 | — |
| +1 | K140273 | Equalizer Occlusion Balloon Catheter | Boston Scientific Corp | 2014 | — |
| +2 | K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +1 | K033670 | Gore Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2004 | — |
| +3 | K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +2 | K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Large Occlusion Balloon Catheter Named without a submission number | |
| * | — | Blue Max Balloon Catheter Named without a submission number |
What descends from it? (33)
See all 336 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 |
|---|---|---|---|---|
| Sep 29, 2009 | Not classified | Z-0194-2010 | Other | Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be… |
| Sep 29, 2009 | Not classified | Z-0195-2010 | Other | Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be… |
| Sep 29, 2009 | Not classified | Z-0196-2010 | Other | Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be… |
| Sep 29, 2009 | Not classified | Z-0197-2010 | Other | Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be… |
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 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K140273 (Boston Scientific Corp, 2014) has gone furthest, with 17 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Equalizer Balloon is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021721: Equalizer 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/K021721
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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