510(k) · Cleared
ClearedFLEX Vessel Prep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venturemed Group, Inc. · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Sep 11, 2020 as substantially equivalent to K152789 (Venturemed Group, 2016) after a 38-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 11, 2020
- Review
- 38 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971010 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK971010 Peripheral Transluminal Angioplasty CathetersCordis Corp. · 1997
- 3 generations backK063657 Vascutrak Pta Dilation CatheterYmed, Inc. · 2006
- 2 generations backK113103 Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical · 2012
- 1 generation backK152789 Flex Scoring CatheterVenturemed Group · 2016
- This deviceK202187 FLEX Vessel Prep SystemVenturemed Group, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971010 | Peripheral Transluminal Angioplasty Catheters | Cordis Corp. | 1997 | — |
| −3 | K063657 | Vascutrak Pta Dilation Catheter | Ymed, Inc. | 2006 | — |
| −2 | K113103 | Splitwire Percutaneous Transluminal Angioplasty Scoring Device | Rex Medical | 2012 | — |
| −1 | K152789 | Flex Scoring Catheter | Venturemed Group | 2016 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K152789 | Flex Scoring CatheterSummary page 5…PAGE 1 PREDICATE DEVICE The subject device is equivalent to the following device: K152789 – FLEX Vessel Prep™ System REFERENCE DEVICE K182713 – Scoreflex PTA Scoring Balloon Catheter. DEVICE DESCRIPTION The FLEX Ves… | 2016 |
| † | K182713 | Scoreflex PTA Scoring Balloon Catheter | 2019 |
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 23 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 FLEX Vessel Prep™ System is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and popliteal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202187: FLEX Vessel Prep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202187
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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