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 Jun 14, 2017 as substantially equivalent to K103459 (C.R. Bard, Inc., 2010) after a 190-day review. Its family tree reaches back 7 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 14, 2017
- Review
- 190 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001134 (2000). 26 ancestors in all, the oldest K971010 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 6 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 5 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 4 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 3 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 2 generations backK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- 1 generation backK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- This deviceK163420 UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK172571 ULTRASCORE Focused Force PTA BalloonC. R. Bard · 2017
- Descendant · cites it directly · 0 of its ownK261778 JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK260012 UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard · 2017 · cites it directly1descendant
- K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2026 · cites it directly0descendants
- K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −6 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −5 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −4 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −3 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −2 | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 2 |
| −1 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| 0 (this device) | K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2017 | — |
| +1 | K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017 | — |
| +1 | K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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 |
|---|---|---|---|
| * | K103459 | Vascutrak Pta Dilatation CatheterSummary page 4…ame: Catheter, Percutaneous, Cutting/Scoring Classification Panel: Cardiovascular Predicate Device: y VASCUTRAK® PTA Dilatation Catheter (K103459; cleared December 13, 2010) Reference Device: x ULTRAVERSE® 035 PTA Dilatation Catheter (K142261; cleared September… | 2010 |
| † | K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | 2014 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K172571 (C. R. Bard, 2017) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K103459.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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/K163420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163420: 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/K163420
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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