510(k) · Cleared
Cleared8FR Turbo - Tandem System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · DQY Catheter, Percutaneous
Cleared on Oct 17, 2011 as substantially equivalent to K094036 (Spectranetics Corp., 2010) after a 94-day review. Its family tree reaches back 13 generations to 1989.
- Decided
- Oct 17, 2011
- Review
- 94 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K890505 (1989). 39 ancestors in all, the oldest K871011 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 9 generations between
- 3 generations backK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled
- 2 generations backK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- 1 generation backK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- This deviceK112032 8FR Turbo - Tandem SystemSpectranetics Corp. · 2011
Show all 13 generations
- Root · 13 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 12 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 11 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 10 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 9 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 8 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 7 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 6 generations backK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- 5 generations backK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
- 4 generations backK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
- 3 generations backK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled
- 2 generations backK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- 1 generation backK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- This deviceK112032 8FR Turbo - Tandem SystemSpectranetics Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −12 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −11 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −10 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −9 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −8 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −7 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −6 | K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | 2005 | — |
| −5 | K052296 | Clirpath Turbo Excimer Laser Catheters | Spectranetics Corp. | 2005 | — |
| −4 | K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152… | Spectranetics Corp. | 2005 | — |
| −3 | K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM… | Spectranetics Corp. | 2007 | 1 |
| −2 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| −1 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| 0 (this device) | K112032 | 8FR Turbo - Tandem System | Spectranetics Corp. | 2011 | — |
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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K094036 | Turbo-Tandem System Model 472-110Summary page 2…tion for Use The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries. Substantially Equivalent Device The Spectranetics 7Fr Turbo-Tandem® System (K094036) is the predicate device to the BFr Turbo- Tandem System. The 8Fr Turbo-Tandem System is similar to the predicate device with reg… | 2010 |
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 22 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 39 ancestors have a recall of any class.
- 1 other device also cites its predicate K094036.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Turbo-Tandem® System is indicated for atherectomy of infrainguinal arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112032: 8FR Turbo - Tandem System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112032
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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