510(k) · Cleared
Recalled · Class I · 2021HawkOne Directional Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Oct 14, 2016 as substantially equivalent to K141801 (Covidien, LLC, 2014) after a 151-day review. Its family tree reaches back 8 generations to 1987. 1 of the 13 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Oct 14, 2016
- Review
- 151 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 8 generations to K871011 (1987). 12 ancestors in all. No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
- 7 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
- 6 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
- 5 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
- 4 generations backK061188 Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc. · 2006 · Recalled
- 3 generations backK093301 Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 2009
- 2 generations backK103618 Turbohawk Peropheral Plaque Excision SystemEv3, Inc. · 2011
- 1 generation backK141801 Hawkone Directional Atherectomy SystemCovidien, LLC · 2014
- This deviceK161361 HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K871011 | Simpson Peripheral Atherocath (TM) | Devices For Vascular Intervention, Inc. | 1987 | — |
| −7 | K024243 | Reform Peripheral Catheter System, Model 02200; Reform Peripheral… | Fox Hollow Technologies | 2003 | 1 |
| −6 | K043553 | Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… | Fox Hollow Technologies | 2005 | — |
| −5 | 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 |
| −3 | K093301 | Turbohawk Peripheral Plaque Excision System | Ev3, Inc. | 2009 | — |
| −2 | K103618 | Turbohawk Peropheral Plaque Excision System | Ev3, Inc. | 2011 | — |
| −1 | K141801 | Hawkone Directional Atherectomy System | Covidien, LLC | 2014 | — |
| 0 (this device) | K161361 | HawkOne Directional Atherectomy System | Medtronic Vascular, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 3 | 0 |
| 2011 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K141801 | Hawkone Directional Atherectomy SystemSummary page 4…W Classification Panel Cardiovascular 3. Predicate Device Device Trade Name HawkOne Directional Atherectomy System (H1-LX and H1-LS) 510(k) Number K141801 510(k) Clearance Date October 16, 2014 4. Reference Device Device Trade Name TurboHawk™ Peripheral Plaque Excision System… | 2014 |
| † | K103618 | Turbohawk Peropheral Plaque Excision System | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2021 | Class I | Z-0451-2022 | Labeling design | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. |
| Dec 6, 2021 | Class I | Z-0450-2022 | Labeling design | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 12 ancestors have a recall of any class.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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/K161361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161361: 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/K161361
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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