Data / Medical devices / Canada / My01, Inc.
My01, Inc.: FDA-registered device maker in Montreal Quebec, Canada, 1 510(k) clearance
My01, Inc. is registered with the FDA (registration 3017398927) in Montreal Quebec, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017398927
- Address
- 400 De Maisonneuve Boulevard West Suite 700, Montreal Quebec, Canada, H3A 1L4
- Owner or operator
- MY01, Inc. (10061277)
- Roles
- Manufacturer
- First device listed
- April 1, 2025
- Registered through
- 2026
- Brand names listed
- MY01 Continuous Compartmental Pressure Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Pressure, Intracompartmental | LXC | U | 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 |
|---|---|---|---|---|---|---|
| March 13, 2025 | K242997 | MY01 Continuous Compartmental Pressure Monitor | LXC | Substantially Equivalent | MY01, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 28, 2021 | 88396 | Class II | Terminated | MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 | There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin. | accessdata.fda.gov |
Compare with other makers
Updated March 13, 2025. 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.