510(k) · Cleared
ClearedRotablator Rotational Atherectomy System with Peripheral Rotalink Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MCW Catheter, Peripheral, Atherectomy
Cleared on Sep 13, 2012 as substantially equivalent to K993648 (Boston Scientific Corporation Northwest Technology, 1999) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Sep 13, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K970296 (1997). 5 ancestors in all, the oldest K913450 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970296 Rotablator Rotational Angioplasty System with the Rotalink…Boston Scientific Corp · 1997
- 1 generation backK993648 Rotablator Rotational Angioplasty System with the Rotalink…Boston Scientific Corporation Northwest Technology · 1999
- This deviceK121774 Rotablator Rotational Atherectomy System with Peripheral Rotalink PlusBoston Scientific Corp · 2012
- Descendant · cites it directly · 1 of its ownK133566 Rotablator Rotational Atherectomy System with the Peripheral…Boston Scientific Corp · 2013
- Descendant · 2 generations on · 0 of its ownK220962 ROTAPRO Rotational Atherectomy SystemBoston Scientific Corporation · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970296 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter | Boston Scientific Corp | 1997 | — |
| −1 | K993648 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter | Boston Scientific Corporation Northwest Technology | 1999 | — |
| 0 (this device) | 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 | — |
| +2 | K220962 | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K993648 | Rotablator Rotational Angioplasty System with the Rotalink Exchangeable CatheterSummary page 1…Peripheral, Atherectomy Classification Class 11,21 CFR Part 870.4875 - Intraluminal Artery Stripper Predicate Peripheral Rotablator@® Rotational K993648 24 November 1999 Device(s) Angioplasty System with the RotaLink Tm Exchangeable Cathet… | 1999 |
| * | K960379 | Rotablator System's Guide Wire Line: Support Rotawire Rail Rota WireSummary page 1…ce(s) Angioplasty System with the RotaLink Tm Exchangeable Catheter Peripheral Rotablator@ Rotational K960379 25 April 1996 Angioplasty System with the Support and Rail RotaWiret m… | 1996 |
| * | K933238 | Rotablator, ModificationSummary page 1…sty System with the Support and Rail RotaWiret m Guidewires Peripheral Rotablatoi® Rotational K933238 24 August 1993 Angioplasty System with Dynaglide RotablatorwireClip… | 1993 |
| * | K913450 | Heart Technology Rotablator WireclipSummary page 1…tational K933238 24 August 1993 Angioplasty System with Dynaglide RotablatorwireClip K913450 06 September 1991 Device The Rotablator Rotational Atherectomy System with the Peripheral Description… | 1991 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133566 | Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus | 2013 | 1 |
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 15 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K133566 (Boston Scientific Corp, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K993648.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 RotablatorTM Rotational Atherectomy System is intended for percutaneous use in 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/K121774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121774: Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121774
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