510(k) · Cleared
ClearedOdyssey Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Jan 21, 2010 after a 112-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 21, 2010
- Review
- 112 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK093092 Odyssey WorkstationStereotaxis, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK253473 SynchronyStereotaxis, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253473SynchronyStereotaxis, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093092 | Odyssey Workstation | Stereotaxis, Inc. | 2010 | — |
| +1 | K253473 | Synchrony | Stereotaxis, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 |
|---|---|---|---|
| * | — | Navigant NWS Named without a submission number |
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 |
|---|---|---|---|
| K253473 | Synchrony | 2026 | 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, K253473 (Stereotaxis, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control of the Catheterization Lab.
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/K093092 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093092: Odyssey Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093092
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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