510(k) · Cleared
ClearedModified Simpson Peripheral Atherocath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devices For Vascular Intervention, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jan 4, 1988 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 118 devices in its family, counting itself, have a Class I recall. 117 later devices descend from it.
- Decided
- Jan 4, 1988
- Review
- 61 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
117 later devices descend from it, 1 citing it directly. 6 of the 118 devices in this family, counting this one, have a Class I recall.
- This deviceK874706 Modified Simpson Peripheral AtherocathDevices For Vascular Intervention, Inc. · 1988
- Descendant · cites it directly · 116 of its ownK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- Descendant · 2 generations on · 79 of its ownK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- Descendant · 3 generations on · 52 of its ownK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- Descendant · 4 generations on · 50 of its ownK061188 Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 37 of its ownK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 117 · See all- K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter…Fox Hollow Technologies · 2003 · cites it directly116descendants
- K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…Fox Hollow Technologies · 2005 · 2 generations on79descendants
- K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…Fox Hollow Technologies · 2006 · 3 generations on52descendants
- K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · 4 generations on50descendants
- K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Foxhollow Technologies, Inc. · 2006 · 4 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K874706 | Modified Simpson Peripheral Atherocath | Devices For Vascular Intervention, Inc. | 1988 | — |
| +1 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| +2 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| +3 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| +4 | K061188 | Silverhawk Peripheral Plaque Excision System | Foxhollow Technologies, Inc. | 2006 | 1 |
| +4 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 9 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 1 |
| 2014 | 8 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 1 |
| 2017 | 8 | 0 |
| 2018 | 8 | 1 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 8 | 2 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 1 |
| 2026 | 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.
6 devices in this family have a Class I recall. 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? (117)
See all 1171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter… | 2003 | 116 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 12 Class I recalls
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K024243 (Fox Hollow Technologies, 2003) has gone furthest, with 116 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/K874706 · printed Nov 5, 2026
Cite this page
510(k) Report. “K874706: Modified Simpson Peripheral Atherocath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K874706
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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