510(k) · Cleared
Recalled · 2010Dorado Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · DQY Catheter, Percutaneous
Cleared on Sep 19, 2007 as substantially equivalent to K014212 (C.R. Bard, Inc., 2002) and 3 other predicates after a 34-day review. Its family tree reaches back 4 generations to 2000. 96 later devices descend from it. It has been recalled 15 times.
- Decided
- Sep 19, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 15
- Predicates
- 4
Its longest line of descent runs back 4 generations to K001134 (2000). 8 ancestors in all. 96 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 3 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 2 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 1 generation backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- This deviceK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007
- Descendant · cites it directly · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- Descendant · cites it directly · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- Descendant · cites it directly · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- Descendant · 3 generations on · 28 of its ownK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · cites it directly44descendants
- K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · cites it directly36descendants
- K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · cites it directly35descendants
- K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 2 generations on29descendants
- K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −3 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −2 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −1 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| 0 (this device) | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | — |
| +1 | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 2 |
| +1 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| +1 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| +2 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| +3 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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.
Planning a device in DQY? 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? (4)
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 |
|---|---|---|---|
| * | K014212 | Bard Conquest Pta Balloon Dilatation CatheterSummary page 1…Classification: Class II Classification Panel: Cardiovascular Predicate Devices: ConquestTM PTA Balloon Dilatation Catheter (K014212, cleared January 17, 2002), manufactured by Bard Peripheral Vascular, Inc. Ultraverse ® Small Vessel PTA Balloon… | 2002 |
| * | K012913 | Bard Utaverse Small Vessel Pta Balloon Dilatation CatheterSummary page 1…Catheter (K014212, cleared January 17, 2002), manufactured by Bard Peripheral Vascular, Inc. Ultraverse ® Small Vessel PTA Balloon Dilatation Catheter (K012913, cleared September 28, 2001), manufactured by Bard Peripheral Vascular, Inc.… | 2001 |
| * | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxSummary page 2…e.%ot3 Page 20 * Sterling TM Over-The-Wire PTA Balloon Dilatation Catheter (K053116, cleared December 16, 2005), manufactured by Boston Scientific Corporation. * PolarCath TM Peripheral Dila… | 2005 |
| * | K060572 | Modification to Polarcath Peripheral Dilatation SystemSummary page 2…atation Catheter (K053116, cleared December 16, 2005), manufactured by Boston Scientific Corporation. * PolarCath TM Peripheral Dilatation System (K060572, cleared March 15, 2006), manufactured by Boston Scientific Corporation. Device Description: The subject device, the Do… | 2006 |
What descends from it? (96)
See all 967 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083657 | Conquest Pta Balloon Dilatation Catheter | 2008 | 44 |
| K103459 | Vascutrak Pta Dilatation Catheter | 2010 | 36 |
| K082579 | Evercross .035 Otw Pta Dilatation Catheter | 2008 | 35 |
| K103751 | Mustang Balloon Dilatation Catheters | 2011 | 15 |
| K120660 | Conquest 40 Pta Dilatation Catheter | 2012 | 3 |
| K120722 | Rival Pta Dilatation Catheter | 2012 | 1 |
| K250219 | Dorado™ PTA Balloon Dilatation Catheter | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2010 | Not classified | Z-2136-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2122-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2124-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2131-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2135-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2129-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2123-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2128-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2132-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2133-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2125-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2134-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2126-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2127-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
| May 4, 2010 | Not classified | Z-2130-2010 | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K083657 (C.R. Bard, Inc., 2008) has gone furthest, with 44 descendants of its own.
- 3 other devices also cite its predicate K014212.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 DoradoTM PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072283: Dorado Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072283
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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