510(k) · Cleared
ClearedTri-Wedge PTA Scoring Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brosmed Medical Co., Ltd. · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Oct 22, 2024 as substantially equivalent to K150634 (Spectranetrics, 2015) after a 151-day review. Its family tree reaches back 13 generations to 1997.
- Decided
- Oct 22, 2024
- Review
- 151 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K971448 (1997). 45 ancestors in all, the oldest K971010 (1997). No later device cites it as a predicate yet.
- Root · 13 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 9 generations between
- 3 generations backK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- 2 generations backK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- 1 generation backK150634 AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015
- This deviceK241478 Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2024
Show all 13 generations
- Root · 13 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 12 generations backK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
- 11 generations backK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
- 10 generations backK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
- 9 generations backK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
- 8 generations backK081220 Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
- 7 generations backK091966 Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040…Angioscore, Inc. · 2009
- 6 generations backK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010
- 5 generations backK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 4 generations backK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 3 generations backK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- 2 generations backK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- 1 generation backK150634 AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015
- This deviceK241478 Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K971448 | Cordis Opta LP Pta Balloon Catheter | Cordis Corp. | 1997 | — |
| −12 | K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | 2001 | — |
| −11 | K050629 | Angiosculpt Scoring Balloon Catheter | Angioscore, Inc. | 2005 | — |
| −10 | K072225 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2007 | 5 |
| −9 | K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | Angioscore, Inc. | 2008 | 5 |
| −8 | K081220 | Modification to Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2008 | — |
| −7 | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 | Angioscore, Inc. | 2009 | — |
| −6 | K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy… | Angioscore, Inc. | 2010 | — |
| −5 | K110767 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −4 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −3 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
| −2 | K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross Caoting | Angioscore, Inc. | 2014 | — |
| −1 | K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015 | — |
| 0 (this device) | K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K150634 | AngioSculpt PTA Scoring Baloon CathetersSummary page 5…Review Panel: Cardiovascular 3. PREDICATE DEVICE AND REFERENCE DEVICES • Primary Predicate Device: AngioSculpt PTA Scoring Balloon Catheter (K150634, cleared on May 31, 2016) • Reference Device: UltraScore Focused Force PTA Balloon (K172571, cleared on September 22, 2017)… | 2015 |
| † | K172571 | ULTRASCORE Focused Force PTA Balloon | 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 27 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 45 ancestors have a recall of any class.
- 2 other devices also cite its predicate K150634.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241478: Tri-Wedge PTA Scoring 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/K241478
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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