MY01, INC.
FDA Regulatory Profile
MY01, INC. appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2384-2021, Class II) was initiated on Jun 28, 2021. Its most recent 510(k) clearance was granted on Jan 16, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2384-2021 | Class II | MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 | Jun 28, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251900 | MY01 Continuous Compartmental Pressure Monitor | Jan 16, 2026 |
| K242997 | MY01 Continuous Compartmental Pressure Monitor | Mar 13, 2025 |
| K220952 | MY01 Continuous Compartmental Pressure Monitor | May 24, 2022 |
| K210525 | MY01 Continuous Compartmental Pressure Monitor | Apr 22, 2021 |
| K202635 | MY01 Continuous Compartmental Pressure Monitor | Dec 10, 2020 |
| K193321 | MY01 Continuous Compartmental Pressure Monitor | Jul 30, 2020 |