510(k) · Cleared
ClearedBolt Intravascular Lithotripsy (IVL) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bolt Medical, Inc. · PPN Percutaneous Catheter, Ultrasound
Cleared on Mar 25, 2025 as substantially equivalent to K161384 (Shockwave Medical, Inc., 2016) after a 57-day review. Its family tree reaches back 14 generations to 1990. 1 later device descends from it.
- Decided
- Mar 25, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- PPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K904788 (1990). 71 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 10 generations between
- 3 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 2 generations backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- 1 generation backK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- This deviceK250225 Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK260246 SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 13 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 12 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 11 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 10 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 9 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 8 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 7 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 6 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 5 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 4 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 3 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 2 generations backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- 1 generation backK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- This deviceK250225 Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −13 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −12 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −11 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −10 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −9 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −8 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −7 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −6 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −5 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −4 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −3 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −2 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
| −1 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| 0 (this device) | K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | 2025 | — |
| +1 | K260246 | SEISMIQ™ Intravascular Lithotripsy System | Bolt 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 |
|---|---|---|---|
| * | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Summary page 5…theter Product Code: PPN Predicate Device The primary predicate for the Bolt IVL Lithotripsy System is the Shockwave Medical Lithoplasty System (K161384) cleared by FDA on September 14, 2016. Reference Device The reference device for the Bolt IVL Lithotripsy System is the Shockwave… | 2016 |
| † | 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 |
|---|---|---|---|
| K260246 | SEISMIQ™ Intravascular Lithotripsy System | 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 35 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 15 of the 71 ancestors have a recall of any class.
- Of its descendants, K260246 (Bolt Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161384.
How does its category compare?
All PPN devicesPPN Percutaneous Catheter, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250225 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250225: Bolt Intravascular Lithotripsy (IVL) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250225
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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