510(k) · Cleared
ClearedSterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx
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 Dec 16, 2005 as substantially equivalent to K050389 (Boston Scientific Corp, 2005) after a 39-day review. Its family tree reaches back 3 generations to 2000. 62 later devices descend from it.
- Decided
- Dec 16, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001134 (2000). 62 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 2 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 1 generation backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- This deviceK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- Descendant · cites it directly · 24 of its ownK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- Descendant · 2 generations on · 23 of its ownK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- Descendant · cites it directly · 21 of its ownK093720 Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL…Boston Scientific Corp · 2009
- Descendant · 3 generations on · 10 of its ownK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- Descendant · 4 generations on · 9 of its ownK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K063563Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterCordis Europa, N.V. · 2007 · cites it directly24descendants
- K071189Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007 · 2 generations on23descendants
- K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp · 2009 · cites it directly21descendants
- K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012 · 3 generations on10descendants
- K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −2 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −1 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| 0 (this device) | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| +1 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| +2 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| +1 | K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL… | Boston Scientific Corp | 2009 | — |
| +3 | K112797 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corp. | 2012 | — |
| +4 | K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corporation | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K050389 | Ultra-Soft SV Balloon Dilatation CatheterSummary page 1…PTA Balloon Dilatation Catheter Product Code DQY Classification of Class II,21 CFR Part 870.1250 Device Predicate Device Ultra-softTM SV K050389 May 25, 2005 Balloon Dilatation Catheter Device T… | 2005 |
What descends from it? (62)
See all 629 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation Catheter | 2007 | 24 |
| K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon… | 2009 | 21 |
| K141150 | Pta Balloon Dilatation Catheter | 2014 | 8 |
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter | 2013 | 8 |
| K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | 2008 | 6 |
| K102482 | Flash Pta Balloon Dilatation Catheter 5MM X 19MM X 135CM; Flash Pta Balloon Dilatation… | 2011 | 5 |
| K121175 | Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CM | 2012 | 3 |
| K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter… | 2016 | 1 |
| K110604 | VBB System | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K063563 (Cordis Europa, N.V., 2007) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K050389.
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 Sterling TM MonorailTM PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053118
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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