510(k) · Cleared
ClearedUltraScore™ Focused Force PTA Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Feb 4, 2026 as substantially equivalent to K172571 (C. R. Bard, 2017) after a 30-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Feb 4, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001134 (2000). 28 ancestors in all, the oldest K971010 (1997). No later device cites it as a predicate yet.
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations between
- 3 generations backK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- 2 generations backK163420 UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2017
- 1 generation backK172571 ULTRASCORE Focused Force PTA BalloonC. R. Bard · 2017
- This deviceK260012 UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 8 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 7 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 6 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 5 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 4 generations backK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- 3 generations backK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- 2 generations backK163420 UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2017
- 1 generation backK172571 ULTRASCORE Focused Force PTA BalloonC. R. Bard · 2017
- This deviceK260012 UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −8 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −7 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −6 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −5 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −4 | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 2 |
| −3 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| −2 | K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2017 | — |
| −1 | K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017 | — |
| 0 (this device) | K260012 | UltraScore™ Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 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 PNO? 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 PNO device
- #1 K261778 JADE SCORE PTA Scoring Balloon Dilatation…score 14.1 · 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 |
|---|---|---|---|
| * | K172571 | ULTRASCORE Focused Force PTA BalloonSummary page 5…ulation Number: 21 CFR 870.1250 Predicate Device: Name of Device: UltraScore™ Focused Force PTA Balloon (K172571, Cleared September 22, 2017) Product Code: PNO Classification Name: Catheter, Percutaneous, Cut… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 28 ancestors have a recall of any class.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PNO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNO
246in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNO
No recall names PNO since 2007.
Adverse event reports per year · PNO
511in 2025
MAUDE reports naming product code PNO, 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 | 3 | 61 | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 23 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 84 | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 3 | 74 | 0 | 26 |
| 2018 | 0 | — | 0 | 55 |
| 2019 | 1 | — | 0 | 81 |
| 2020 | 4 | 94 | 0 | 121 |
| 2021 | 1 | — | 0 | 90 |
| 2022 | 2 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 4 | 246 | 0 | 537 |
| 2025 | 2 | — | 0 | 511 |
| 2026 | 3 | 110 | 0 | — |
What is it indicated for?
The UltraScore™ Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal 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 stents, self-expanding stents, and stent grafts in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260012: UltraScore™ Focused Force PTA Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260012
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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