510(k) · Cleared
ClearedCri Steerable Catheter Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Research C/O Burditt, Bowles & Radzius · DXX System, Catheter Control, Steerable
Cleared on Dec 17, 1990 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Dec 17, 1990
- Review
- 55 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 DXX? 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 DXX device
- #1 K251792 Stereotaxis GenesisX RMN with Navigant ™…score 13.9 · 3 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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXX
76in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXX
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXX
1in 2024
MAUDE reports naming product code DXX, 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 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 4 | 155 | 0 | 2 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 4 | 104 | 1 | 14 |
| 2015 | 4 | 156 | 0 | 2 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 3 | 76 | 0 | 9 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K904787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904787: Cri Steerable Catheter Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904787
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026