510(k) · Cleared
ClearedAngiosculpt Scoring Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angioscore, Inc. · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Sep 2, 2005 as substantially equivalent to K013581 (Cordis, A Johnson & Johnson Co., 2001) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 1997. 38 later devices descend from it.
- Decided
- Sep 2, 2005
- Review
- 175 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971448 (1997). 7 ancestors in all, the oldest K971010 (1997). 38 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 1 generation backK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
- This deviceK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
- Descendant · cites it directly · 37 of its ownK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
- Descendant · cites it directly · 36 of its ownK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 34 of its ownK082059 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
- Descendant · 2 generations on · 34 of its ownK081220 Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
- Descendant · 2 generations on · 33 of its ownK091966 Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040…Angioscore, Inc. · 2009
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K072225Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · cites it directly37descendants
- K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · cites it directly36descendants
- K082059Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008 · 2 generations on34descendants
- K081220Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008 · 2 generations on34descendants
- K091966Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040Angioscore, Inc. · 2009 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971448 | Cordis Opta LP Pta Balloon Catheter | Cordis Corp. | 1997 | — |
| −1 | K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | 2001 | — |
| 0 (this device) | K050629 | Angiosculpt Scoring Balloon Catheter | Angioscore, Inc. | 2005 | — |
| +1 | K072225 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2007 | 5 |
| +1 | K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | Angioscore, Inc. | 2008 | 5 |
| +2 | K082059 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2008 | — |
| +2 | K081220 | Modification to Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2008 | — |
| +2 | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 | Angioscore, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K013581 | Cordis Aviator Peripheral Dilatation CatheterSummary page 4…/ Usual Name Angioplasty catheter Classification Name Catheter, angioplasty, peripheral, transluminal (L.IT) Predicate Devices Cordis Aviator® PTA Dilatation Catheter (K013581) Cordis Savvy® PTA Dilatation Catheter (K971010) 3. Intended Usc / Indications The AngioSculpt Scoring Balloon Catheter is inte… | 2001 |
| * | K971010 | Peripheral Transluminal Angioplasty CathetersSummary page 4…n Name Catheter, angioplasty, peripheral, transluminal (L.IT) Predicate Devices Cordis Aviator® PTA Dilatation Catheter (K013581) Cordis Savvy® PTA Dilatation Catheter (K971010) 3. Intended Usc / Indications The AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapo… | 1997 |
What descends from it? (38)
See all 384 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072225 | Angiosculpt Pta Scoring Balloon Catheter | 2007 | 37 |
| K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | 2008 | 36 |
| K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy | 2010 | 32 |
| K110767 | Angiosculpt Pta Scoring Balloon Catheter | 2011 | 30 |
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 8 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K072225 (Angioscore, Inc., 2007) has gone furthest, with 37 descendants of its own.
- 3 other devices also cite its predicate K013581.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
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/K050629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050629: Angiosculpt Scoring Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050629
Report an extraction error
Are you the manufacturer?
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