510(k) · Cleared
ClearedTurbo Tracker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · DQO Catheter, Intravascular, Diagnostic
Cleared on May 2, 1996 after a 64-day review. The FDA summary names its predicate without a number. 186 later devices descend from it.
- Decided
- May 2, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
186 later devices descend from it, 8 citing it directly.
- This deviceK960806 Turbo TrackerTarget Therapeutics · 1996
- Descendant · cites it directly · 120 of its ownK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- Descendant · 2 generations on · 81 of its ownK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- Descendant · cites it directly · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- Descendant · 2 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- Descendant · 3 generations on · 39 of its ownK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 186 · See all- K994155Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000 · cites it directly120descendants
- K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · 2 generations on81descendants
- K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · cites it directly50descendants
- K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 2 generations on46descendants
- K083343Headway 17 MicrocatheterMicroVention, Inc. · 2008 · 3 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| +1 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| +2 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| +1 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| +2 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| +3 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 8 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 12 | 0 |
| 2020 | 12 | 0 |
| 2021 | 5 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 11 | 0 |
| 2025 | 8 | 0 |
| 2026 | 8 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | — | Target Therapeutics’ Hydrophilic Tracker Infusion Catheter Named without a submission number |
What descends from it? (186)
See all 1868 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994155 | Excelsior 1018 Microcatheter | 2000 | 120 |
| K030637 | Ekos Peripheral Infusion System | 2003 | 50 |
| K020733 | PVS 1500 SDS | 2002 | 21 |
| K041826 | Ekos Ultrasound Infusion System | 2005 | 19 |
| K032624 | Micrus Microcatheter | 2003 | 19 |
| K063620 | Ekos Micro-Infusion System | 2007 | 12 |
| K993292 | Boston Scientific/Target Sentry Occlusion Balloon Catheter | 2000 | 6 |
| K974222 | Ces Masstransit Infusion Catheter | 1998 | 0 |
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?
- Of its descendants, K994155 (Boston Scientific, Target, 2000) has gone furthest, with 120 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
TurboTRACKERS are intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents such as occlusion coils into the peripheral, coronary, and neuro vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960806: Turbo Tracker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960806
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