510(k) · Cleared
ClearedTracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft, Tracker-17 Microcatheter, 150 CM Long and 7.5 CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · DQY Catheter, Percutaneous
Cleared on Jan 3, 2013 as substantially equivalent to K994155 (Boston Scientific, Target, 2000) after a 56-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jan 3, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960806 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 1 generation backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- This deviceK123452 Tracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal…Stryker · 2013
- Descendant · cites it directly · 0 of its ownK142565 Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter…Stryker Neurovascular · 2014
Most influential descendants
Showing 1 of 1 · See all- K142565Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17…Stryker Neurovascular · 2014 · cites it directly0descendants
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) | K123452 | Tracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft… | Stryker | 2013 | — |
| +1 | K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior… | Stryker Neurovascular | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K994155 | Excelsior 1018 MicrocatheterSummary page 1…for these devices. Legally Marketed Predicate Device: Reference (Clearance Date) Device K994155 (3 Aug 2010) Tracker Excel- 14 Microcatheters Page I of 3 510(k)… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17… | 2014 | 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142565 (Stryker Neurovascular, 2014) has gone furthest, with 0 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. 2013, 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?
Stryker Neurovascular's Tracker-17 Microcatheters 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 as stated in the FDA summary.
https://510kreport.com/device/K123452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123452: Tracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft, Tracker-17 Microcatheter, 150 CM Long and 7.5 CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123452
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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