Chrysalis Intelligence · Sponsors · MY01, Inc.

MY01, Inc.

Montreal, CA · 6 510(k) clearances · 1 recalls

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Total clearances

6

2020-07-30 → 2026-01-16

Last 12 months

1

Product codes

1

Most recent

2026-01-16

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
LXC	Monitor, Pressure, Intracompartmental	Unclassified	Unknown	6	2026-01-16

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

0

Most recent

2021-06-28

Date	Severity	Status	Recall #	Product	Code	Reason
2021-06-28	Class II	Terminated	Z-2384-2021	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 w…

Filings

All 510(k) clearances (6)

Date	K-number	Device	Code	Class	Specialty
2026-01-16	K251900	MY01 Continuous Compartmental Pressure Monitor	LXC	Unclassified	Unknown
2025-03-13	K242997	MY01 Continuous Compartmental Pressure Monitor	LXC	Unclassified	Unknown
2022-05-24	K220952	MY01 Continuous Compartmental Pressure Monitor	LXC	Unclassified	Unknown
2021-04-22	K210525	MY01 Continuous Compartmental Pressure Monitor	LXC	Unclassified	Unknown
2020-12-10	K202635	MY01 Continuous Compartmental Pressure Monitor	LXC	Unclassified	Unknown
2020-07-30	K193321	MY01 Continuous Compartmental Pressure Monitor	LXC	Unclassified	Unknown