510(k) · Cleared
ClearedB-Laser Atherectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eximo Medical, Ltd. · MCW Catheter, Peripheral, Atherectomy
Cleared on Oct 5, 2018 as substantially equivalent to K140775 (Spectranetics Corporation, 2014) after a 106-day review. Its family tree reaches back 14 generations to 1989. 8 later devices descend from it.
- Decided
- Oct 5, 2018
- Review
- 106 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K890505 (1989). 40 ancestors in all, the oldest K871011 (1987). 8 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 10 generations between
- 3 generations backK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- 2 generations backK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- 1 generation backK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- This deviceK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018
- Descendant · cites it directly · 6 of its ownK202835 Auryon Atherectomy SystemEximo Medical, Ltd. · 2020
- Descendant · 2 generations on · 4 of its ownK220116 Auryon Atherectomy CathetersEximo Medical, Ltd. · 2022
- Descendant · 3 generations on · 3 of its ownK230709 Auryon Atherectomy SystemEximo Medical, Ltd. · 2023
- Descendant · 4 generations on · 2 of its ownK233668 Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating…Eximo Medical, Ltd. · 2023
- Descendant · 5 generations on · 0 of its ownK260244 Auryon Atherectomy SystemEximo Medical · 2026
Show all 14 generations
- Root · 14 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 13 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 12 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 11 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 10 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 9 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 8 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 7 generations backK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- 6 generations backK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
- 5 generations backK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
- 4 generations backK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled
- 3 generations backK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- 2 generations backK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- 1 generation backK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- This deviceK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K202835Auryon Atherectomy SystemEximo Medical, Ltd. · 2020 · cites it directly6descendants
- K220116Auryon Atherectomy CathetersEximo Medical, Ltd. · 2022 · 2 generations on4descendants
- K230709Auryon Atherectomy SystemEximo Medical, Ltd. · 2023 · 3 generations on3descendants
- K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd. · 2023 · 4 generations on2descendants
- K260244Auryon Atherectomy SystemEximo Medical · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −13 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −12 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −11 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −10 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −9 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −8 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −7 | K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | 2005 | — |
| −6 | K052296 | Clirpath Turbo Excimer Laser Catheters | Spectranetics Corp. | 2005 | — |
| −5 | K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152… | Spectranetics Corp. | 2005 | — |
| −4 | K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM… | Spectranetics Corp. | 2007 | 1 |
| −3 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| −2 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| −1 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
| 0 (this device) | K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018 | — |
| +1 | K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2020 | — |
| +2 | K220116 | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | 2022 | — |
| +3 | K230709 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2023 | — |
| +4 | K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000)… | Eximo Medical, Ltd. | 2023 | — |
| +5 | K260244 | Auryon Atherectomy System | Eximo Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSummary page 4…atheter Classification 21 CFR 870.4875, Class II, product code MCW Predicate Devices Spectranetics Turbo-Tandem System and Turbo Elite Laser Catheters (K140775) (Primary Predicate) Phoenix® Atherectomy System (K132682) (Reference Device) Intended Use / Indications for Use… | 2014 |
| † | K132682 | Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter… | 2014 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 40 ancestors have a recall of any class.
- Of its descendants, K202835 (Eximo Medical, Ltd., 2020) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K140775.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 B-Laser Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181642: B-Laser 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/K181642
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