510(k) · Cleared
ClearedHawkone Directional Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · MCW Catheter, Peripheral, Atherectomy
Cleared on Oct 16, 2014 as substantially equivalent to K111723 (Ev3, Inc., 2011) and 1 other predicate after a 105-day review. Its family tree reaches back 7 generations to 1987. 1 of the 13 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 16, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K871011 (1987). 11 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 6 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 5 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 4 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 3 generations backK061188 Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · Recalled
- 2 generations backK093301 Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 2009
- 1 generation backK103618 Turbohawk Peropheral Plaque Excision SystemEv3, Inc. · 2011
- This deviceK141801 Hawkone Directional Atherectomy SystemCovidien, LLC · 2014
- Descendant · cites it directly · 0 of its ownK161361 HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016 · Recalled (Class I)
Class I recalls in this family
- K161361 HawkOne Directional Atherectomy Systemcites it directly · 2016
Most influential descendants
Showing 1 of 1 · See all- K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −6 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −5 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −4 | 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 |
| −2 | K093301 | Turbohawk Peripheral Plaque Excision System | Ev3, Inc. | 2009 | — |
| −1 | K103618 | Turbohawk Peropheral Plaque Excision System | Ev3, Inc. | 2011 | — |
| 0 (this device) | K141801 | Hawkone Directional Atherectomy System | Covidien, LLC | 2014 | — |
| +1 | K161361 | HawkOne Directional Atherectomy System | Medtronic Vascular, Inc. | 2016 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 1 |
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.
1 device in this family has 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? (2)
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 |
|---|---|---|---|
| * | K111723 | Turbohawk Peripheral Plaque Excision SystemSummary page 4…uct Code MCW Classification Panel Cardiovascular 3. Predicate Devices Device Trade Name TurboHawk™ Peripheral Plaque Excision System 510(k) Number K111723 510(k) Clearance Date October 27, 2011 Device Trade Name TurboHawk™ Peripheral Plaque Excision System 510(k) Numb… | 2011 |
| * | K103618 | Turbohawk Peropheral Plaque Excision SystemSummary page 4…System 510(k) Number K111723 510(k) Clearance Date October 27, 2011 Device Trade Name TurboHawk™ Peripheral Plaque Excision System 510(k) Number K103618 510(k) Clearance Date January 5, 2011 4. Device Description The HawkOne™ directional atherectomy system (HawkOne catheter and… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161361 | HawkOne Directional Atherectomy System Class I | 2016 | 0 |
Has anything in its family been recalled? (1 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.
- K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K161361 (Medtronic Vascular, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111723.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 HawkOne Directional Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141801: Hawkone Directional Atherectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141801
Report an extraction error
Are you the manufacturer?
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