Data / Medical devices / Canada / Opsens Inc.
Opsens Inc.: FDA-registered device maker in Quebec City, Canada, 10 510(k) clearances
Opsens Inc. is registered with the FDA (registration 3008061490) in Quebec City, Canada. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated January 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008061490
- Address
- 750, Boulevard du Parc Technologique, Quebec City, Canada, G1P 4S3
- Owner or operator
- Opsens Inc. (10049773)
- Roles
- Manufacturer
- First device listed
- July 27, 2015
- Registered through
- 2026
- Brand names listed
- OptoMonitor, OptoMonitor 2, OptoMonitor 3, OptoMonitor System, OptoWire, OptoWire Deux, OptoWire III, OptoWire One and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunctive Cardiovascular Status Indicator | PPW | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Pacemaker, Temporary | LDF | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2026 | K251367 | OptoMonitor 3 | DXO | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| February 12, 2025 | K241418 | OptoMonitor 3 | DXO | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| May 24, 2024 | K240864 | PacePro Wire | DQX | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| September 14, 2022 | K213854 | SavvyWire | DQX | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| November 24, 2020 | K202943 | OptoMonitor 3 | DXO | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| June 18, 2020 | K193620 | OptoMonitor 3 | DXO | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| January 2, 2020 | K191907 | OptoWire III | DQX | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| September 13, 2016 | K161263 | OptoMonitor II | DXO | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
| February 11, 2016 | K152991 | OptoWire Deux | DQX | Substantially Equivalent | Opsens | accessdata.fda.gov |
| June 12, 2015 | K142598 | Opto Wire and OptoMonitor System | DQX | Substantially Equivalent | Opsens, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Wire, Guide, Catheter
- All makers of Electrode, Pacemaker, Temporary
- All makers of Adjunctive Cardiovascular Status Indicator
Updated January 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.