Cleared Traditional

K202635 - MY01 Continuous Compartmental Pressure Monitor (FDA 510(k) Clearance)

K202635 · MY01, Inc. · Orthopedic device
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Dec 2020
Decision
90d
Days
-
Risk

K202635 is an FDA 510(k) clearance for the MY01 Continuous Compartmental Pressure Monitor. Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by MY01, Inc. (Montreal, CA). The FDA issued a Cleared decision on December 10, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all MY01, Inc. devices

Submission Details

510(k) Number K202635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2020
Decision Date December 10, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -

Regulatory Peers - LXC Monitor, Pressure, Intracompartmental

All 14
Devices cleared under the same product code (LXC) and FDA review panel - the closest regulatory comparables to K202635.
MY01 Continuous Compartmental Pressure Monitor
K251900 · MY01, Inc. · Jan 2026
MY01 Continuous Compartmental Pressure Monitor
K242997 · MY01, Inc. · Mar 2025
Compremium Compartment Compressibility Monitoring System (CPM#1)
K223509 · Compremium AG · Apr 2023
MY01 Continuous Compartmental Pressure Monitor
K220952 · MY01, Inc. · May 2022
MY01 Continuous Compartmental Pressure Monitor
K210525 · MY01, Inc. · Apr 2021