FDA product code DXX: System, Catheter Control, Steerable
DXX is the FDA product code for system, catheter control, steerable. It is a Class II device, regulated under 21 CFR 870.1290 and reviewed by the Cardiovascular panel. FDA has cleared 34 510(k) submissions under DXX, 4 in the last five years, from 8 different applicants. The average 510(k) review took 162 days (median 125); 116 days on average over the last three years. FDA has posted 4 recalls for DXX devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Catheter Control, Steerable |
| Device class | Class II |
| Regulation | 21 CFR 870.1290 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 76 |
| 2020 | 1 | 122 |
| 2022 | 1 | 69 |
| 2025 | 2 | 208 |
| 2026 | 1 | 24 |
Compare with all 510(k) review times · Search every DXX clearance
Top DXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stereotaxis, Inc. | 9 | 2026-08-27 |
| Corindus, Inc. | 9 | 2022-07-27 |
| Hansen Medical, Inc. | 9 | 2015-07-23 |
| Catheter Robotics, Inc. | 2 | 2012-11-20 |
| Catheter Research C/O Burditt, Bowles & Radzius | 2 | 1993-05-26 |
3 more applicants have DXX clearances. See the full list in Caduvo.
Most recent DXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262744 | Stereotaxis, Inc. | GenesisX RMN | 2026-08-27 | 24 |
| K251792 | Stereotaxis, Inc. | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | 2025-11-06 | 148 |
| K243789 | Microbot Medical , Ltd. | LIBERTY Endovascular Robotic System (LIBERTYOS) | 2025-09-04 | 269 |
| K221464 | Corindus, Inc. | CorPath GRX System | 2022-07-27 | 69 |
| K202275 | Corindus, Inc. | CorPath GRX System | 2020-12-11 | 122 |
Recalls for DXX devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-25.
Frequently asked questions
What is FDA product code DXX?
DXX is the FDA product code for system, catheter control, steerable. It is a Class II device, regulated under 21 CFR 870.1290 and reviewed by the Cardiovascular panel.
What device class is DXX?
Class II, regulation 21 CFR 870.1290. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXX?
Across 34 cleared submissions the average was 162 days from receipt to decision (median 125).
Which companies have the most DXX clearances?
Stereotaxis, Inc. (9); Corindus, Inc. (9); Hansen Medical, Inc. (9); Catheter Robotics, Inc. (2); Catheter Research C/O Burditt, Bowles & Radzius (2).
Have DXX devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2016-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code DXX
- Run a recall and safety report across every DXX manufacturer
- Watch product code DXX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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