510(k) · Cleared
ClearedEndosonics Trak Back Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endosonics Corp. · DQX Wire, Guide, Catheter
Cleared on Aug 30, 1999 after a 214-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 30, 1999
- Review
- 214 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK990271 Endosonics Trak Back DeviceEndosonics Corp. · 1999
- Descendant · cites it directly · 2 of its ownK021802 Stereotaxis Catheter Advancer SystemStereotaxis, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK042850 Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)Stereotaxis, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK051374 Cardiodrive Catheter Advancement SystemStereotaxis, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K021802Stereotaxis Catheter Advancer SystemStereotaxis, Inc. · 2003 · cites it directly2descendants
- K042850Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)Stereotaxis, Inc. · 2006 · 2 generations on0descendants
- K051374Cardiodrive Catheter Advancement SystemStereotaxis, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990271 | Endosonics Trak Back Device | Endosonics Corp. | 1999 | — |
| +1 | K021802 | Stereotaxis Catheter Advancer System | Stereotaxis, Inc. | 2003 | — |
| +2 | K042850 | Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile) | Stereotaxis, Inc. | 2006 | — |
| +2 | K051374 | Cardiodrive Catheter Advancement System | Stereotaxis, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | EndoSonics Automatic Pull Back Device Named without a submission number | |
| * | — | CVIS Catheter Pull-Back Device Named without a submission number | |
| * | — | Intertherapy Interpret Catheter Linear Translator Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021802 | Stereotaxis Catheter Advancer System | 2003 | 2 |
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, K021802 (Stereotaxis, Inc., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Trak Back can be used with the Visions Five-64 series ultrasound imaging catheter. The Trak Back withdraws the imaging catheter from the vessel through the guide catheter.
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/K990271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990271: Endosonics Trak Back Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990271
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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