510(k) · Cleared
ClearedROTAPRO Rotational Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · MCW Catheter, Peripheral, Atherectomy
Cleared on Sep 6, 2022 as substantially equivalent to K133566 (Boston Scientific Corp, 2013) after a 158-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 6, 2022
- Review
- 158 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970296 (1997). 8 ancestors in all, the oldest K901206 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK970296 Rotablator Rotational Angioplasty System with the Rotalink…Boston Scientific Corp · 1997
- 3 generations backK993648 Rotablator Rotational Angioplasty System with the Rotalink…Boston Scientific Corporation Northwest Technology · 1999
- 2 generations backK121774 Rotablator Rotational Atherectomy System with Peripheral Rotalink PlusBoston Scientific Corp · 2012
- 1 generation backK133566 Rotablator Rotational Atherectomy System with the Peripheral…Boston Scientific Corp · 2013
- This deviceK220962 ROTAPRO Rotational Atherectomy SystemBoston Scientific Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970296 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter | Boston Scientific Corp | 1997 | — |
| −3 | K993648 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter | Boston Scientific Corporation Northwest Technology | 1999 | — |
| −2 | K121774 | Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus | Boston Scientific Corp | 2012 | — |
| −1 | K133566 | Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K220962 | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 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.
Planning a device in MCW? 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 |
|---|---|---|---|
| * | K133566 | Rotablator Rotational Atherectomy System with the Peripheral Rotalink PlusSummary page 4…duct Code MCW – Catheter, Peripheral, Atherectomy Classification Class II, 21 CFR Part 870.4875 – Intraluminal Artery Stripper Predicate Device K133566 -- RotablatorTM Rotational Atherectomy System with Peripheral RotaLink PlusTM Reference Devices P90… | 2013 |
| † | P900056 | Rotablator (R) | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220962: ROTAPRO Rotational 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/K220962
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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