FDA product code DXO: Transducer, Pressure, Catheter Tip
DXO is the FDA product code for transducer, pressure, catheter tip. It is a Class II device, regulated under 21 CFR 870.2870 and reviewed by the Cardiovascular panel. FDA has cleared 64 510(k) submissions under DXO, 4 in the last five years, from 35 different applicants. The average 510(k) review took 127 days (median 105); 249 days on average over the last three years. FDA has posted 10 recalls for DXO devices.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Pressure, Catheter Tip |
| Device class | Class II |
| Regulation | 21 CFR 870.2870 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 106 |
| 2018 | 1 | 27 |
| 2019 | 4 | 102 |
| 2020 | 2 | 115 |
| 2022 | 1 | 150 |
| 2024 | 1 | 219 |
| 2025 | 1 | 268 |
| 2026 | 1 | 260 |
Compare with all 510(k) review times · Search every DXO clearance
Top DXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Millar Instruments, Inc. | 7 | 2011-10-18 |
| Opsens, Inc. | 6 | 2026-01-16 |
| Edwards Lifesciences, LLC | 5 | 2022-12-22 |
| Camino Laboratories, Inc. | 5 | 1987-05-27 |
| Radi Medical Systems AB | 4 | 2008-07-01 |
30 more applicants have DXO clearances. See the full list in Caduvo.
Most recent DXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251367 | Opsens, Inc. | OptoMonitor 3 | 2026-01-16 | 260 |
| K241418 | Opsens, Inc. | OptoMonitor 3 | 2025-02-12 | 268 |
| K233904 | Acist Medical Systems, Inc. | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | 2024-07-17 | 219 |
| K222216 | Edwards Lifesciences, LLC | TruWave Disposable Pressure Transducer | 2022-12-22 | 150 |
| K202943 | Opsens, Inc. | OptoMonitor 3 | 2020-11-24 | 55 |
Recalls for DXO devices
10 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-05-26.
| Year | Recalls |
|---|---|
| 2021 | 8 |
Frequently asked questions
What is FDA product code DXO?
DXO is the FDA product code for transducer, pressure, catheter tip. It is a Class II device, regulated under 21 CFR 870.2870 and reviewed by the Cardiovascular panel.
What device class is DXO?
Class II, regulation 21 CFR 870.2870. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXO?
Across 64 cleared submissions the average was 127 days from receipt to decision (median 105).
Which companies have the most DXO clearances?
Millar Instruments, Inc. (7); Opsens, Inc. (6); Edwards Lifesciences, LLC (5); Camino Laboratories, Inc. (5); Radi Medical Systems AB (4).
Have DXO devices been recalled?
Yes: 10 product recalls across 3 recall events; the most recent began 2021-05-26.
Next steps
- Run an FDA pathway report with predicate devices for product code DXO
- Run a recall and safety report across every DXO manufacturer
- Watch product code DXO 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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