510(k) · Cleared
ClearedSplitwire Percutaneous Transluminal Angioplasty Scoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rex Medical · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on May 22, 2012 as substantially equivalent to K063657 (Ymed, Inc., 2006) after a 216-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- May 22, 2012
- Review
- 216 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971010 (1997). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971010 Peripheral Transluminal Angioplasty CathetersCordis Corp. · 1997
- 1 generation backK063657 Vascutrak Pta Dilation CatheterYmed, Inc. · 2006
- This deviceK113103 Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical · 2012
- Descendant · cites it directly · 2 of its ownK193495 XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific · 2020
- Descendant · 2 generations on · 1 of its ownK221986 XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter…Transit Scientific, LLC · 2022
- Descendant · cites it directly · 1 of its ownK152789 Flex Scoring CatheterVenturemed Group · 2016
- Descendant · 3 generations on · 0 of its ownK232258 XO Constrain™ Percutaneous Transluminal Angioplasty Constraining…Transit Scientific, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK202187 FLEX Vessel Prep SystemVenturemed Group, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific · 2020 · cites it directly2descendants
- K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC · 2022 · 2 generations on1descendant
- K152789Flex Scoring CatheterVenturemed Group · 2016 · cites it directly1descendant
- K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC · 2024 · 3 generations on0descendants
- K202187FLEX Vessel Prep SystemVenturemed Group, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971010 | Peripheral Transluminal Angioplasty Catheters | Cordis Corp. | 1997 | — |
| −1 | K063657 | Vascutrak Pta Dilation Catheter | Ymed, Inc. | 2006 | — |
| 0 (this device) | K113103 | Splitwire Percutaneous Transluminal Angioplasty Scoring Device | Rex Medical | 2012 | — |
| +1 | K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | 2020 | — |
| +2 | K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score… | Transit Scientific, LLC | 2022 | — |
| +1 | K152789 | Flex Scoring Catheter | Venturemed Group | 2016 | — |
| +3 | K232258 | XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | 2024 | — |
| +2 | K202187 | FLEX Vessel Prep System | Venturemed Group, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K063657 | Vascutrak Pta Dilation CatheterSummary page 4…ed: October 14, 2011 Name of the Device: SplitWire Percutaneous Transluminal Angioplasty Scoring Device Predicate Device Information: VascuTrak PTA Dilation Catheter (K063657) Device Description: The SplitWire Percutaneous Transluminal Angioplasty Scoring Device is designed to facilitate the dilatatio… | 2006 |
What descends from it? (5)
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 15 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K193495 (Transit Scientific, 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K063657.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 SplitWire Percutaneous Transluminal Angioplasty Scoring device is indicated for the use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and 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/K113103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113103: Splitwire Percutaneous Transluminal Angioplasty Scoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113103
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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