510(k) · Cleared
ClearedAngiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy
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 Mar 22, 2010 as substantially equivalent to K013581 (Cordis, A Johnson & Johnson Co., 2001) and 9 other predicates after a 47-day review. Its family tree reaches back 7 generations to 1997. 32 later devices descend from it.
- Decided
- Mar 22, 2010
- Review
- 47 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 7 generations to K971448 (1997). 19 ancestors in all, the oldest K971010 (1997). 32 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 6 generations backK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
- 5 generations backK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
- 4 generations backK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
- 3 generations backK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
- 2 generations backK081220 Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
- 1 generation backK091966 Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040…Angioscore, Inc. · 2009
- This deviceK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010
- Descendant · cites it directly · 30 of its ownK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- Descendant · cites it directly · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- Descendant · cites it directly · 29 of its ownK101735 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc. · 2010
- Descendant · 2 generations on · 28 of its ownK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- Descendant · 2 generations on · 24 of its ownK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · cites it directly30descendants
- K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · cites it directly29descendants
- K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc. · 2010 · cites it directly29descendants
- K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013 · 2 generations on28descendants
- K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971448 | Cordis Opta LP Pta Balloon Catheter | Cordis Corp. | 1997 | — |
| −6 | K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | 2001 | — |
| −5 | K050629 | Angiosculpt Scoring Balloon Catheter | Angioscore, Inc. | 2005 | — |
| −4 | K072225 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2007 | 5 |
| −3 | K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | Angioscore, Inc. | 2008 | 5 |
| −2 | K081220 | Modification to Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2008 | — |
| −1 | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 | Angioscore, Inc. | 2009 | — |
| 0 (this device) | K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy… | Angioscore, Inc. | 2010 | — |
| +1 | K110767 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| +1 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| +1 | K101735 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-Xxyy | Angioscore, Inc. | 2010 | — |
| +2 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
| +2 | K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross Caoting | Angioscore, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (10)
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…sty catheter Classification Name: Qatheter, angioplasty, periphergl, transluminal Product Codes: DQY and LIT Predicate Devices: Cordis Aviator® PTA Dilatation Catheter {K013581) Cordis Savvy® PTA Dilatation Catheter (K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Cathet… | 2001 |
| * | K971010 | Peripheral Transluminal Angioplasty CathetersSummary page 4…plasty, periphergl, transluminal Product Codes: DQY and LIT Predicate Devices: Cordis Aviator® PTA Dilatation Catheter {K013581) Cordis Savvy® PTA Dilatation Catheter (K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Cathet… | 1997 |
| * | K063657 | Vascutrak Pta Dilation CatheterSummary page 4…: DQY and LIT Predicate Devices: Cordis Aviator® PTA Dilatation Catheter {K013581) Cordis Savvy® PTA Dilatation Catheter (K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082058… | 2006 |
| * | K082343 | Vascutrak 2, Models: V14 and V18Summary page 4…or® PTA Dilatation Catheter {K013581) Cordis Savvy® PTA Dilatation Catheter (K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082058, K091966) 3. Intended Use / Indications Th… | 2008 |
| * | K050629 | Angiosculpt Scoring Balloon CatheterSummary page 4…vy® PTA Dilatation Catheter (K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082058, K091966) 3. Intended Use / Indications The AngioSculpt PTA Scoring Balloon Catheter is int… | 2005 |
| * | K072225 | Angiosculpt Pta Scoring Balloon CatheterSummary page 4…ilatation Catheter (K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082058, K091966) 3. Intended Use / Indications The AngioSculpt PTA Scoring Balloon Catheter is intended for… | 2007 |
| * | K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Summary page 4…Catheter (K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082058, K091966) 3. Intended Use / Indications The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatati… | 2008 |
| * | K081220 | Modification to Angiosculpt Pta Scoring Balloon CatheterSummary page 4…(K971010) VascuTrak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082058, K091966) 3. Intended Use / Indications The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of les… | 2008 |
| * | K082059 | Angiosculpt Pta Scoring Balloon Catheter Our OCR of the scanned summary read K082058, FDA’s number for Dynamatrix (Cook Biotech, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AngioSculpt Scoring Balloon Catheter”. | 2008 |
| * | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040Summary page 4…ak'f‘ PTA Dilatation Catheter (K063657) VascuTrak™ PTA Dilatation Catheter (K082343) AngioSculpt® Scoring Balloon Catheter (K050629, K072225, K080151, K081220, K082058, K091966) 3. Intended Use / Indications The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the liac,… | 2009 |
What descends from it? (32)
See all 323 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 13 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K110767 (Angioscore, Inc., 2011) has gone furthest, with 30 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. 2010, 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 AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstruclive lesions of native or synthetic arteriovenous dialysis fistulae. 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/K100303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100303: Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100303
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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