510(k) · Cleared
ClearedShockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shockwave Medical, Inc. · PPN Percutaneous Catheter, Ultrasound
Cleared on Mar 22, 2024 as substantially equivalent to K191840 (Shockwave Medical, Inc., 2019) after a 56-day review. Its family tree reaches back 17 generations to 1990. 1 later device descends from it.
- Decided
- Mar 22, 2024
- Review
- 56 days
- Class
- Class II
- Product code
- PPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K904788 (1990). 74 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 13 generations between
- 3 generations backK163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty…Shockwave Medical, Inc. · 2016
- 2 generations backK180454 Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. · 2018 · Recalled
- 1 generation backK191840 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator…Shockwave Medical, Inc. · 2019
- This deviceK240225 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave…Shockwave Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK262201 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave…Shockwave Medical, Inc. · 2026
Show all 17 generations
- Root · 17 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 16 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 15 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 14 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 13 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 12 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 11 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 10 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 9 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 8 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 7 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 6 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 5 generations backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- 4 generations backK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- 3 generations backK163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty…Shockwave Medical, Inc. · 2016
- 2 generations backK180454 Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. · 2018 · Recalled
- 1 generation backK191840 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator…Shockwave Medical, Inc. · 2019
- This deviceK240225 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave…Shockwave Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −16 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −15 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −14 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −13 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −12 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −11 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −10 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −9 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −8 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −7 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −6 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −5 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
| −4 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| −3 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And… | Shockwave Medical, Inc. | 2016 | — |
| −2 | K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2018 | 1 |
| −1 | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and… | Shockwave Medical, Inc. | 2019 | — |
| 0 (this device) | K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8… | Shockwave Medical, Inc. | 2024 | — |
| +1 | K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8… | Shockwave Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 PPN? 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 PPN device
- #1 K262201 Shockwave Intravascular Lithotripsy (IVL)…score 16.9 · 18 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 |
|---|---|---|---|
| * | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Summary page 5…e: Percutaneous catheter Product Code: PPN Predicate Device The predicate device is the Shockwave Medical Intravascular Lithotripsy System, K191840, cleared by FDA on August 7, 2019. Reference Device The reference device is the Shockwave Medical Intravascular Lithotripsy Syst… | 2019 |
| † | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL… | 2021 |
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 |
|---|---|---|---|
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL… | 2026 | 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 34 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 16 of the 74 ancestors have a recall of any class.
- Of its descendants, K262201 (Shockwave Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K191840.
How does its category compare?
All PPN devicesPPN Percutaneous Catheter, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PPN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PPN
56in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PPN
No recall names PPN since 2007.
Adverse event reports per year · PPN
43in 2025
MAUDE reports naming product code PPN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 18 |
| 2022 | 2 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 3 | 56 | 0 | 45 |
| 2025 | 1 | — | 0 | 43 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral 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/K240225 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240225: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240225
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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