510(k) · Cleared
ClearedSchneider Total Cross and Match 35 Percutanewous Transluminal Angioplasty Catheters
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 Aug 18, 1994 after a 125-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 18, 1994
- Review
- 125 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK942154 Schneider Total Cross and Match 35 Percutanewous Transluminal…Boston Scientific Scimed, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK972512 Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular…Boston Scientific Scimed, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK021996 Bolton Pta CatheterBolton Medical, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK992320 Megabello Percutaneous Transluminal Angioplasty (Pta) CatheterBoston Scientific Corp · 2000
Most influential descendants
Showing 3 of 3 · See all- K972512Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices PanelBoston Scientific Scimed, Inc. · 1998 · cites it directly2descendants
- K021996Bolton Pta CatheterBolton Medical, Inc. · 2002 · 2 generations on0descendants
- K992320Megabello Percutaneous Transluminal Angioplasty (Pta) CatheterBoston Scientific Corp · 2000 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942154 | Schneider Total Cross and Match 35 Percutanewous Transluminal Angioplasty… | Boston Scientific Scimed, Inc. | 1994 | — |
| +1 | K972512 | Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel | Boston Scientific Scimed, Inc. | 1998 | — |
| +2 | K021996 | Bolton Pta Catheter | Bolton Medical, Inc. | 2002 | — |
| +2 | K992320 | Megabello Percutaneous Transluminal Angioplasty (Pta) Catheter | Boston Scientific Corp | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972512 | Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel | 1998 | 2 |
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?
- Of its descendants, K972512 (Boston Scientific Scimed, Inc., 1998) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K942154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942154: Schneider Total Cross and Match 35 Percutanewous Transluminal Angioplasty Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942154
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026