510(k) · Cleared
ClearedSEISMIQ™ Intravascular Lithotripsy 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 Aug 24, 2026 as substantially equivalent to K250225 (Bolt Medical, Inc., 2025) after a 209-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Aug 24, 2026
- Review
- 209 days
- Class
- Class II
- Product code
- PPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K904788 (1990). 72 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 11 generations between
- 3 generations backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- 2 generations backK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- 1 generation backK250225 Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc. · 2025
- This deviceK260246 SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 14 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 13 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 12 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 11 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 10 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 9 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 8 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 7 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 6 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 5 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 4 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 3 generations backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- 2 generations backK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- 1 generation backK250225 Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc. · 2025
- This deviceK260246 SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −14 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −13 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −12 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −11 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −10 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −9 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −8 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −7 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −6 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −5 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −4 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −3 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
| −2 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| −1 | K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | 2025 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K250225 | Bolt Intravascular Lithotripsy (IVL) SystemSummary page 5…evice The primary predicate for the SEISMIQ Intravascular Lithotripsy (IVL) System is the SEISMIQ Intravascular Lithotripsy System (Previously named the Bolt IVL System, K250225) cleared by FDA on March 25, 2025. Reference Device The reference device for the Bolt IVL Lithotripsy System is the Shockwave Med… | 2025 |
| † | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable… | 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 36 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 15 of the 72 ancestors have a recall of any class.
How does its category compare?
All PPN devicesPPN Percutaneous Catheter, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SEISMIGMVL 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260246: SEISMIQ™ Intravascular Lithotripsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260246
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026