510(k) · Cleared
ClearedRotablator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heart Technology, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Sep 14, 1990 after a 184-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 103 devices in its family, counting itself, have a Class I recall. 102 later devices descend from it.
- Decided
- Sep 14, 1990
- Review
- 184 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 0
102 later devices descend from it, 6 citing it directly. 4 of the 103 devices in this family, counting this one, have a Class I recall.
- This deviceK901206 RotablatorHeart Technology, Inc. · 1990
- Descendant · cites it directly · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- Descendant · cites it directly · 34 of its ownK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 33 of its ownK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 32 of its ownK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
- Descendant · cites it directly · 30 of its ownK041630 Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems Incorporated · 2005
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 102 · See all- K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · cites it directly36descendants
- K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · cites it directly34descendants
- K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008 · 2 generations on33descendants
- K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008 · 2 generations on32descendants
- K041630Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems Incorporated · 2005 · cites it directly30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901206 | Rotablator | Heart Technology, Inc. | 1990 | — |
| +1 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| +1 | K081328 | Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| +2 | K082186 | Modification to Pathway PV Atherectomy System | Pathway Medical Technologies, Inc. | 2008 | — |
| +2 | K082664 | Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 | Pathway Medical Technologies, Inc. | 2008 | — |
| +1 | K041630 | Orbital Atherectomy System for Treatment of a-V Shunt Stenosis | Cardiovascular Systems Incorporated | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 1 |
| 2014 | 7 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 1 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 1 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 1 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (102)
See all 1026 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040067 | Clirpath Excimer Laser Catheter | 2004 | 36 |
| K081328 | Pathway PV Atherectomy System | 2008 | 34 |
| K041630 | Orbital Atherectomy System for Treatment of a-V Shunt Stenosis | 2005 | 30 |
| K071350 | Diamondback 360 Degree Orbital Atherectomy System | 2007 | 28 |
| K191419 | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire | 2019 | 1 |
| K133566 | Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus | 2013 | 1 |
Has anything in its family been recalled? (4 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.
- K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K040067 (Spectranetics Corp., 2004) has gone furthest, with 36 descendants of its own.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K901206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901206: Rotablator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901206
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026