Cleared Traditional

K210525 - MY01 Continuous Compartmental Pressure Monitor (FDA 510(k) Clearance)

K210525 · MY01, Inc. · Orthopedic device
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Apr 2021
Decision
58d
Days
-
Risk

K210525 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 April 22, 2021 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all MY01, Inc. devices

Submission Details

510(k) Number K210525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2021
Decision Date April 22, 2021
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K210525.
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