Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list MY01, Inc. with 6 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jan 16, 2026: MY01 Continuous Compartmental Pressure Monitor.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 16, 2026 | MY01 Continuous Compartmental Pressure MonitorK251900 · LXC | 510(k) clearances |
| Mar 13, 2025 | MY01 Continuous Compartmental Pressure MonitorK242997 · LXC | 510(k) clearances |
| May 24, 2022 | MY01 Continuous Compartmental Pressure MonitorK220952 · LXC | 510(k) clearances |
| Jun 28, 2021 | MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001Class II · There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using | Device recalls |
| Apr 22, 2021 | MY01 Continuous Compartmental Pressure MonitorK210525 · LXC | 510(k) clearances |
| Dec 10, 2020 | MY01 Continuous Compartmental Pressure MonitorK202635 · LXC | 510(k) clearances |
| Jul 30, 2020 | MY01 Continuous Compartmental Pressure MonitorK193321 · LXC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
