Cleared Traditional

MY01 Continuous Compartmental Pressure Monitor (K193321) - FDA 510(k) Clearance

K193321 · MY01, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
241d
Days
-
Risk

K193321 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 July 30, 2020 after a review of 241 days - an extended review 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: 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 K193321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date July 30, 2020
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -

Regulatory Peers - LXC Monitor, Pressure, Intracompartmental

All 9
Devices cleared under the same product code (LXC) and FDA review panel - the closest regulatory comparables to K193321.
MY01 Continuous Compartmental Pressure Monitor
K220952 · MY01, Inc. · May 2022
MY01 Continuous Compartmental Pressure Monitor
K210525 · MY01, Inc. · Apr 2021
MY01 Continuous Compartmental Pressure Monitor
K202635 · MY01, Inc. · Dec 2020
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · Synthes (Usa) · Jul 2003
ACE ICPM SIDE PORTED NEEDLE
K881858 · Buckman Co., Inc. · May 1988
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K844214 · Stryker Corp. · Apr 1985