510(k) · Cleared
ClearedTracker Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · DQY Catheter, Percutaneous
Cleared on Oct 1, 1986 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 1, 1986
- Review
- 120 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK862117 Tracker Infusion CatheterTarget Therapeutics · 1986
- Descendant · cites it directly · 6 of its ownK151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom…Cathera, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK180959 Phenom 27 CatheterCathera, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK210230 Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021
- Descendant · 3 generations on · 0 of its ownK260199 SLIM MicrocatheterBalt USA, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK251668 SurfRider 13 MicrocatheterKaneka Americas Holding, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc. · 2015 · cites it directly6descendants
- K180959Phenom 27 CatheterCathera, Inc. · 2018 · 2 generations on4descendants
- K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021 · 2 generations on2descendants
- K260199SLIM MicrocatheterBalt USA, LLC · 2026 · 3 generations on0descendants
- K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862117 | Tracker Infusion Catheter | Target Therapeutics | 1986 | — |
| +1 | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | Cathera, Inc. | 2015 | — |
| +2 | K180959 | Phenom 27 Catheter | Cathera, Inc. | 2018 | — |
| +2 | K210230 | Phenom Catheters | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2021 | — |
| +3 | K260199 | SLIM Microcatheter | Balt USA, LLC | 2026 | — |
| +3 | K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 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?
- Of its descendants, K151638 (Cathera, Inc., 2015) has gone furthest, with 6 descendants of its own.
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) | — |
https://510kreport.com/device/K862117 · printed Nov 4, 2026
Cite this page
510(k) Report. “K862117: Tracker Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862117
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026