510(k) Report

FDA applicant

MY01, Inc.

Montreal, CA6 decisions2020–20261 recall

FDA records 6 decisions for MY01, Inc. (Montreal, CA) from 2020 to 2026: 6 510(k) clearances. All are in product code LXC (Monitor, Pressure, Intracompartmental). Its devices cite 6 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided MY01, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 22021: 12022: 12025: 12026 (partial year): 1
2020high 2 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2020high 1 (2021) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — MY01, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like MY01, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LXCMonitor, Pressure, Intracompartmental6decisions

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 20212cite it
  • K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 20251cites it
  • K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 20201cites it
  • K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 20201cites it
  • K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 20221cites it

What has FDA decided for it lately?

  • K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026
  • K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
  • K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
  • K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 20211 recall
  • K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
  • K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020

All 6 as MY01, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K210525MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001Jun 28, 2021Class II