510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MY01, Inc.

Montreal Quebec, CA

MY01, INC. appears in FDA device records in Montreal Quebec, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for MY01, Inc. between 2020 and 2026. The busiest year on record is 2020, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for MY01, Inc., by decision year
YearClearances
20202
20211
20221
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251900MY01 Continuous Compartmental Pressure MonitorLXCSubstantially Equivalent
K242997MY01 Continuous Compartmental Pressure MonitorLXCSubstantially Equivalent
K220952MY01 Continuous Compartmental Pressure MonitorLXCSubstantially Equivalent
K210525MY01 Continuous Compartmental Pressure MonitorLXCSubstantially Equivalent
K202635MY01 Continuous Compartmental Pressure MonitorLXCSubstantially Equivalent
K193321MY01 Continuous Compartmental Pressure MonitorLXCSubstantially Equivalent

Registered establishments

FDA registered establishments for MY01, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30173989273017398927MY01, INC.400 De Maisonneuve Boulevard West, Montreal Quebec H3A 1L4 CA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2384-2021MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001There 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 which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain