510(k) · Cleared
ClearedTurbo-Elite Laser Atherectomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics · MCW Catheter, Peripheral, Atherectomy
Cleared on Mar 13, 2025 as substantially equivalent to K170059 (Spectranetics, Inc., 2017) after a 30-day review. Its family tree reaches back 15 generations to 1989.
- Decided
- Mar 13, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K890505 (1989). 41 ancestors in all, the oldest K871011 (1987). No later device cites it as a predicate yet.
- Root · 15 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 11 generations between
- 3 generations backK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- 2 generations backK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- 1 generation backK170059 Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc. · 2017 · Recalled
- This deviceK250385 Turbo-Elite Laser Atherectomy CatheterSpectranetics · 2025
Show all 15 generations
- Root · 15 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 14 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 13 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 12 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 11 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 10 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 9 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 8 generations backK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- 7 generations backK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
- 6 generations backK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
- 5 generations backK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled
- 4 generations backK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- 3 generations backK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- 2 generations backK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- 1 generation backK170059 Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc. · 2017 · Recalled
- This deviceK250385 Turbo-Elite Laser Atherectomy CatheterSpectranetics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −14 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −13 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −12 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −11 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −10 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −9 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −8 | K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | 2005 | — |
| −7 | K052296 | Clirpath Turbo Excimer Laser Catheters | Spectranetics Corp. | 2005 | — |
| −6 | K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152… | Spectranetics Corp. | 2005 | — |
| −5 | K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM… | Spectranetics Corp. | 2007 | 1 |
| −4 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| −3 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| −2 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
| −1 | K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Spectranetics, Inc. | 2017 | 3 |
| 0 (this device) | K250385 | Turbo-Elite Laser Atherectomy Catheter | Spectranetics | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K170059 | Spectranetics Turbo-Elite Laser Atherectomy CathetersSummary page 5…Class II Review Panel: Cardiovascular Regulation Number: 21 CFR 870.4875 Predicate Device Turbo-Elite Laser Atherectomy Catheter (K170059; cleared April 07, 2017) Indications for use The Turbo-Elite devices are indicated for use in the treatment, including atherecto… | 2017 |
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 36 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 41 ancestors have a recall of any class.
- 1 other device also cites its predicate K170059.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Turbo-Elite devices are indicated for use in treatment, including atherectomy, of infrainguinal stenoses and occlusions.
The 0.014" and 0.018" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250385: Turbo-Elite Laser Atherectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250385
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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