510(k) · Cleared
ClearedSmash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Feb 12, 1998 as substantially equivalent to K913297 (Schneider Intl., Ltd., 1991) and 2 other predicates after a 220-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Feb 12, 1998
- Review
- 220 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K913297 (1991). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913297 Schneider Match-35(TM) Percu Trans Angioplas CathSchneider Intl., Ltd. · 1991
- This deviceK972512 Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular…Boston Scientific Scimed, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK021996 Bolton Pta CatheterBolton Medical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK992320 Megabello Percutaneous Transluminal Angioplasty (Pta) CatheterBoston Scientific Corp · 2000
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913297 | Schneider Match-35(TM) Percu Trans Angioplas Cath | Schneider Intl., Ltd. | 1991 | — |
| 0 (this device) | K972512 | Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel | Boston Scientific Scimed, Inc. | 1998 | — |
| +1 | K021996 | Bolton Pta Catheter | Bolton Medical, Inc. | 2002 | — |
| +1 | K992320 | Megabello Percutaneous Transluminal Angioplasty (Pta) Catheter | Boston Scientific Corp | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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 |
|---|---|---|---|
| * | K913297 | Schneider Match-35(TM) Percu Trans Angioplas CathSummary page 1…Transluminal Angioplasty (PTA) Catheter Percutaneous Transluminal Angioplasty (PTA) Catheter Class I Match-35™ Percutaneous Transluminal Angioplasty (PTA) Catheter - K913297, K926271 and K942154 The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a bilumen catheter with a contr… | 1991 |
| * | K926271 | Schneider Match-35 Percutaneous Transluminal AngioSummary page 1…inal Angioplasty (PTA) Catheter Percutaneous Transluminal Angioplasty (PTA) Catheter Class I Match-35™ Percutaneous Transluminal Angioplasty (PTA) Catheter - K913297, K926271 and K942154 The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a bilumen catheter with a controlled-com… | 1993 |
| * | K942154 | Schneider Total Cross and Match 35 Percutanewous Transluminal Angioplasty CathetersSummary page 1…asty (PTA) Catheter Percutaneous Transluminal Angioplasty (PTA) Catheter Class I Match-35™ Percutaneous Transluminal Angioplasty (PTA) Catheter - K913297, K926271 and K942154 The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a bilumen catheter with a controlled-compliance bali… | 1994 |
What descends from it? (2)
2 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K021996 (Bolton Medical, Inc., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.
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/K972512 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972512: Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972512
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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