MY01, Inc.: FDA clearances and approvals
MY01, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 129 days. Since 2017 its median was 129 days, against 143 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named MY01, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 166 |
| 2021 | 1 | 58 |
| 2022 | 1 | 53 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 168 |
| 2026 | 1 | 210 |
Review time against the same product codes
Since 2017, MY01, Inc.'s cleared 510(k)s took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LXC | Monitor, Pressure, Intracompartmental | 6 | 6 |
Review panels
- Orthopedic (6)
Most recent MY01, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251900 | MY01 Continuous Compartmental Pressure Monitor | LXC | 2026-01-16 | 210 |
| K242997 | MY01 Continuous Compartmental Pressure Monitor | LXC | 2025-03-13 | 168 |
| K220952 | MY01 Continuous Compartmental Pressure Monitor | LXC | 2022-05-24 | 53 |
| K210525 | MY01 Continuous Compartmental Pressure Monitor | LXC | 2021-04-22 | 58 |
| K202635 | MY01 Continuous Compartmental Pressure Monitor | LXC | 2020-12-10 | 90 |
| K193321 | MY01 Continuous Compartmental Pressure Monitor | LXC | 2020-07-30 | 241 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-06-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
MY01, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04012723: Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome (Completed, started 2020-11-17)
- NCT04016103: MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time (Completed, started 2020-07-17)
Frequently asked questions
How many FDA 510(k) clearances does MY01, Inc. have?
MY01, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear MY01, Inc.'s 510(k)s?
The median time from FDA receipt to decision across MY01, Inc.'s cleared 510(k)s is 129 days. Since 2017: 129 days, versus 143 days for all cleared 510(k)s in the same product codes.
What devices does MY01, Inc. make?
Its most frequent FDA product codes are LXC (Monitor, Pressure, Intracompartmental, 6).
Has MY01, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches MY01, Inc; the most recent began 2021-06-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 MY01, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LXC, MY01, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.