PMA · Approved
Recalled · Class I · 2022Rotablator (R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MCX Catheter, Coronary, Atherectomy
Approved on May 28, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 1,004-day review. It has a Class I recall. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- May 28, 1993
- Review
- 1,004 days
- Class
- Class III
- Product code
- MCX
- Recalls
- 4 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P900056 has 219 supplements since 1993: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 7 |
| 1997 | 3 |
| 1998 | 3 |
| 1999 | 7 |
| 2000 | 28 |
| 2001 | 7 |
| 2002 | 9 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 5 |
| 2009 | 3 |
| 2010 | 5 |
| 2011 | 7 |
| 2012 | 9 |
| 2013 | 11 |
| 2014 | 13 |
| 2015 | 7 |
| 2016 | 5 |
| 2017 | 11 |
| 2018 | 6 |
| 2019 | 6 |
| 2020 | 9 |
| 2021 | 5 |
| 2022 | 7 |
| 2023 | 12 |
| 2024 | 3 |
| 2025 | 5 |
| 2026 | 6 |
Sources: FDA PMA database (decision fields and supplements), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Mar 8, 2022 | Class II | Z-0915-2022 | Process control | Pouch seals may be open, compromising sterility. |
| Mar 8, 2022 | Class II | Z-0916-2022 | Process control | Pouch seals may be open, compromising sterility. |
| Oct 9, 2015 | Class I | Z-0211-2016 | Component change control | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire… |
| Oct 9, 2015 | Class I | Z-0212-2016 | Component change control | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MCX devicesMCX Catheter, Coronary, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCX
Too few MCX 510(k)s in any year since 2007 to give a median.
Recalls per year · MCX
2in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MCX
864in 2025
MAUDE reports naming product code MCX, 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 | 8 | — | 2 | 107 |
| 2008 | 8 | — | 0 | 185 |
| 2009 | 10 | — | 0 | 289 |
| 2010 | 5 | — | 0 | 319 |
| 2011 | 12 | — | 0 | 333 |
| 2012 | 10 | — | 0 | 293 |
| 2013 | 13 | — | 0 | 355 |
| 2014 | 18 | — | 0 | 412 |
| 2015 | 25 | — | 2 (2) | 629 |
| 2016 | 16 | — | 0 | 713 |
| 2017 | 23 | — | 0 | 735 |
| 2018 | 13 | — | 0 | 876 |
| 2019 | 15 | — | 1 | 788 |
| 2020 | 20 | — | 0 | 822 |
| 2021 | 9 | — | 1 | 901 |
| 2022 | 12 | — | 2 | 720 |
| 2023 | 18 | — | 0 | 706 |
| 2024 | 9 | — | 0 | 798 |
| 2025 | 10 | — | 0 | 864 |
| 2026 | 10 | — | 0 | — |
https://510kreport.com/device/P900056 · printed Nov 6, 2026
Cite this page
510(k) Report. “P900056: Rotablator (R).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900056
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026