510(k) · Cleared
Recalled · 2004Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fox Hollow Technologies · MCW Catheter, Peripheral, Atherectomy
Cleared on Jun 20, 2003 as substantially equivalent to K871011 (Devices For Vascular Intervention, Inc., 1987) and 3 other predicates after a 179-day review. Its family tree reaches back 1 generation to 1987. 6 of the 121 devices in its family, counting itself, have a Class I recall. 116 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 2003
- Review
- 179 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K871011 (1987). 4 ancestors in all. 116 later devices descend from it, 4 citing it directly. 6 of the 121 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- This deviceK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003
- Descendant · cites it directly · 79 of its ownK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- Descendant · 2 generations on · 52 of its ownK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- Descendant · 3 generations on · 50 of its ownK061188 Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 37 of its ownK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
- Descendant · cites it directly · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
Showing 5 of 116 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 116 · See all- K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…Fox Hollow Technologies · 2005 · cites it directly79descendants
- K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…Fox Hollow Technologies · 2006 · 2 generations on52descendants
- K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · 3 generations on50descendants
- K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Foxhollow Technologies, Inc. · 2006 · 3 generations on37descendants
- K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| 0 (this device) | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | — |
| +1 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| +2 | K053460 | Modification to Silverhawk Peripheral Plaque Excision System, Models 02550… | Fox Hollow Technologies | 2006 | — |
| +3 | K061188 | Silverhawk Peripheral Plaque Excision System | Foxhollow Technologies, Inc. | 2006 | 1 |
| +3 | K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models… | Foxhollow Technologies, Inc. | 2006 | — |
| +1 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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 MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 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? (4)
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 |
|---|---|---|---|
| * | K871011 | Simpson Peripheral Atherocath (TM)Summary page 1…Simpson Peripheral Atherocath Predicate Device Manufacturer(s) Devices for Vascular Intervention Predicate Device Reference(s) K871011, K874706, K881088, K883346 Predicate Device Proprietary Name(s) Simpson PeripheraI At herocath Predicate Device Classificat… | 1987 |
| * | K874706 | Modified Simpson Peripheral AtherocathSummary page 1…Simpson Peripheral Atherocath Predicate Device Manufacturer(s) Devices for Vascular Intervention Predicate Device Reference(s) K871011, K874706, K881088, K883346 Predicate Device Proprietary Name(s) Simpson PeripheraI At herocath Predicate Device Classification Name(… | 1988 |
| * | K881088 | Addition of a Tip Guard to the Atherocath (TM)Summary page 1…Simpson Peripheral Atherocath Predicate Device Manufacturer(s) Devices for Vascular Intervention Predicate Device Reference(s) K871011, K874706, K881088, K883346 Predicate Device Proprietary Name(s) Simpson PeripheraI At herocath Predicate Device Classification Name(s) Cathet… | 1988 |
| * | K883346 | Simpson Peripheral Atherocath W/Addit. Size 13FSummary page 1…on Peripheral Atherocath Predicate Device Manufacturer(s) Devices for Vascular Intervention Predicate Device Reference(s) K871011, K874706, K881088, K883346 Predicate Device Proprietary Name(s) Simpson PeripheraI At herocath Predicate Device Classification Name(s) Catheter, Angio… | 1988 |
What descends from it? (116)
See all 1164 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706… | 2005 | 79 |
| K040067 | Clirpath Excimer Laser Catheter | 2004 | 36 |
| K081328 | Pathway PV Atherectomy System | 2008 | 34 |
| K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter… | 2014 | 6 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2004 | Not classified | Z-1091-04 | Other | Devices for which sterility may be compromised. |
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 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 12 Class I recalls
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 6 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K043553 (Fox Hollow Technologies, 2005) has gone furthest, with 79 descendants of its own.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ReFORM Peripheral Catheter System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024243: Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024243
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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