510(k) · Cleared
ClearedXO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transit Scientific, LLC · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Oct 18, 2022 as substantially equivalent to K193495 (Transit Scientific, 2020) after a 104-day review. Its family tree reaches back 14 generations to 1997. 1 later device descends from it.
- Decided
- Oct 18, 2022
- Review
- 104 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K971448 (1997). 47 ancestors in all, the oldest K971010 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 10 generations between
- 3 generations backK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- 2 generations backK150634 AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015
- 1 generation backK193495 XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific · 2020
- This deviceK221986 XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter…Transit Scientific, LLC · 2022
- Descendant · cites it directly · 0 of its ownK232258 XO Constrain™ Percutaneous Transluminal Angioplasty Constraining…Transit Scientific, LLC · 2024
Show all 14 generations
- Root · 14 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 13 generations backK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
- 12 generations backK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
- 11 generations backK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
- 10 generations backK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
- 9 generations backK081220 Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
- 8 generations backK091966 Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040…Angioscore, Inc. · 2009
- 7 generations backK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010
- 6 generations backK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 5 generations backK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 4 generations backK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- 3 generations backK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- 2 generations backK150634 AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015
- 1 generation backK193495 XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific · 2020
- This deviceK221986 XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter…Transit Scientific, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K971448 | Cordis Opta LP Pta Balloon Catheter | Cordis Corp. | 1997 | — |
| −13 | K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | 2001 | — |
| −12 | K050629 | Angiosculpt Scoring Balloon Catheter | Angioscore, Inc. | 2005 | — |
| −11 | K072225 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2007 | 5 |
| −10 | K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | Angioscore, Inc. | 2008 | 5 |
| −9 | K081220 | Modification to Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2008 | — |
| −8 | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 | Angioscore, Inc. | 2009 | — |
| −7 | K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy… | Angioscore, Inc. | 2010 | — |
| −6 | K110767 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −5 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −4 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
| −3 | K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross Caoting | Angioscore, Inc. | 2014 | — |
| −2 | K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015 | — |
| −1 | K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | 2020 | — |
| 0 (this device) | K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score… | Transit Scientific, LLC | 2022 | — |
| +1 | K232258 | XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | 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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring CatheterSummary page 4…Percutaneous Catheter 21 CFR §870.1250, Product Code PNO Device Class: Class II Predicate Device: 510(k) No.: K193495 Model: XO Score Percutaneous Transluminal Angioplasty Scoring Cathete… | 2020 |
| † | K193420 | XO Cross Support Catheter | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232258 | XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter | 2024 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 47 ancestors have a recall of any class.
- Of its descendants, K232258 (Transit Scientific, LLC, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221986 · printed Nov 3, 2026
Cite this page
510(k) Report. “K221986: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K221986
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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