OptoMonitor II
FDA 510(k) K161263 · Opsens, Inc.
510(k) numberK161263
Submission
- Device name
- OptoMonitor II
- Applicant
- Opsens, Inc.
Quebec, CA - Received
- May 5, 2016
- Decision date
- September 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXO – Transducer, Pressure, Catheter Tip
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2870
- Specialty
- Cardiovascular
Other 510(k)s with product code DXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 02/12/2025SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | Acist Medical Systems, Inc. | 07/17/2024SE |
| K222216 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 12/22/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 06/18/2020SE |
| K193279 | Comet II Pressure GuidewireDXO · Special | Boston Scientific Corporation | 12/23/2019SE |
| K192340 | OptoMonitorDXO · Traditional | Opsens, Inc. | 12/12/2019SE |
| K190852 | Zurich Pressure Guidewire System Model 100DXO · Traditional | Zurich Medical, Inc. | 08/14/2019SE |
| K183413 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifeciences, LLC | 05/01/2019SE |
More from Edwards Lifeciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | 02/12/2025SE |
| K240864 | PacePro WireDQX · Traditional | 05/24/2024SE |
| K213854 | SavvyWireDQX · Traditional | 09/14/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | 06/18/2020SE |
| K191907 | OptoWire IIIDQX · Traditional | 01/02/2020SE |
| K192340 | OptoMonitorDXO · Traditional | 12/12/2019SE |
| K152991 | OptoWire DeuxDQX · Traditional | 02/11/2016SE |
| K142598 | Opto Wire and OptoMonitor SystemDQX · Traditional | 06/12/2015SE |
Questions and answers
When was OptoMonitor II cleared by the FDA?
OptoMonitor II (K161263) received a 510(k) decision of Substantially Equivalent on September 13, 2016, 131 days after the submission was received.
What is the product code of K161263?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.