510(k) · Cleared
ClearedLithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
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 Sep 14, 2016 as substantially equivalent to K142983 (Angioscore, Inc., 2015) and 2 other predicates after a 118-day review. Its family tree reaches back 13 generations to 1990. 13 later devices descend from it.
- Decided
- Sep 14, 2016
- Review
- 118 days
- Class
- Class II
- Product code
- PPN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K904788 (1990). 70 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 9 generations between
- 3 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 2 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 1 generation backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- This deviceK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- Descendant · cites it directly · 10 of its ownK163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty…Shockwave Medical, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK180958 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter…Shockwave Medical, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK180454 Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 3 of its ownK191840 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator…Shockwave Medical, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK250225 Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 12 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 11 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 10 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 9 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 8 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 7 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 6 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 5 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 4 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 3 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 2 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 1 generation backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- This deviceK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc. · 2016 · cites it directly10descendants
- K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc. · 2018 · 2 generations on4descendants
- K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. · 2018 · 2 generations on4descendants
- K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc. · 2019 · 3 generations on3descendants
- K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc. · 2025 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −12 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −11 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −10 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −9 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −8 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −7 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −6 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −5 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −4 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −3 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −2 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −1 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
| 0 (this device) | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| +1 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And… | Shockwave Medical, Inc. | 2016 | — |
| +2 | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter… | Shockwave Medical, Inc. | 2018 | — |
| +2 | K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2018 | 1 |
| +3 | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and… | Shockwave Medical, Inc. | 2019 | — |
| +1 | K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | 2025 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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 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 16.8 · 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? (3)
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 |
|---|---|---|---|
| * | K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingSummary page 4…e: PPN Predicate Device The primary predicate for the Shockwave Medical Lithoplasty System is the Spectranetics, Inc. AngioSculpt PTA Scoring Balloon Catheter (K142983). Additional predicates in terms of intended use and technologic characteristics are the Bard Peripheral Vascular VascuTrak PTA D… | 2015 |
| * | K103459 | Vascutrak Pta Dilatation CatheterSummary page 4…on Catheter (K142983). Additional predicates in terms of intended use and technologic characteristics are the Bard Peripheral Vascular VascuTrak PTA Dilatation Catheter (K103459) and the EKOS Corporation EKOS Lysus Micro-Infusion System (K060422). Indications for Use / Intended Use The Shockwave Medical L… | 2010 |
| * | K060422 | Lysus Infusion SystemSummary page 4…e and technologic characteristics are the Bard Peripheral Vascular VascuTrak PTA Dilatation Catheter (K103459) and the EKOS Corporation EKOS Lysus Micro-Infusion System (K060422). Indications for Use / Intended Use The Shockwave Medical Lithoplasty System is intended for lithotripsy-enhanced balloon dilat… | 2006 |
What descends from it? (13)
See all 132 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 26 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 15 of the 70 ancestors have a recall of any class.
- Of its descendants, K163306 (Shockwave Medical, Inc., 2016) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K142983.
How does its category compare?
All PPN devicesPPN Percutaneous Catheter, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Lithoplasty 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 or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161384
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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