510(k) · Cleared
ClearedTracker Excel -14 Pre-Shaped Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQY Catheter, Percutaneous
Cleared on Jun 3, 2005 as substantially equivalent to K994155 (Boston Scientific, Target, 2000) after an 86-day review. Its family tree reaches back 2 generations to 1996. 35 later devices descend from it.
- Decided
- Jun 3, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960806 (1996). 35 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 1 generation backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- This deviceK050599 Tracker Excel -14 Pre-Shaped MicrocatheterBoston Scientific Corp · 2005
- Descendant · cites it directly · 34 of its ownK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- Descendant · cites it directly · 33 of its ownK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- Descendant · 2 generations on · 20 of its ownK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
- Descendant · 2 generations on · 11 of its ownK161126 ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016
- Descendant · 2 generations on · 9 of its ownK112035 Valet Micro CatheterVolcano Corporation · 2012
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K062885Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007 · cites it directly34descendants
- K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009 · cites it directly33descendants
- K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015 · 2 generations on20descendants
- K161126ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016 · 2 generations on11descendants
- K112035Valet Micro CatheterVolcano Corporation · 2012 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −1 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| 0 (this device) | K050599 | Tracker Excel -14 Pre-Shaped Microcatheter | Boston Scientific Corp | 2005 | — |
| +1 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| +1 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| +2 | K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2015 | — |
| +2 | K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | 2016 | — |
| +2 | K112035 | Valet Micro Catheter | Volcano Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K994155 | Excelsior 1018 MicrocatheterSummary page 1…herapeutic agents, such as occlusion coils into the peripheral, coronary, and neuro vasculature. Predicate Device(s): TrackerTM Excel rM- 14 Microcatheter (510(k) # K994155 cleared August 3, 2000) Testing in Support of Substantial Equivalence Determination The predicate device which was originally… | 2000 |
| † | K962503 | Guglielmi Detachable Coil | 1996 |
| † | K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables… | 2000 |
What descends from it? (35)
See all 352 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 9 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062885 (Asahi Intecc Co., Ltd., 2007) has gone furthest, with 34 descendants of its own.
- 3 other devices also cite its predicate K994155.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Boston Scientific's TrackerTM ExcelTM-14 Pre-ShapedMicrocatheter is 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 as stated in the FDA summary.
https://510kreport.com/device/K050599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050599: Tracker Excel -14 Pre-Shaped Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050599
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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