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510(k) K210525

MY01 Continuous Compartmental Pressure Monitor by MY01, Inc. — Product Code LXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2021
Date Received
February 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intracompartmental
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by MY01, Inc.

  • K251900 — MY01 Continuous Compartmental Pressure Monitor (January 16, 2026)
  • K242997 — MY01 Continuous Compartmental Pressure Monitor (March 13, 2025)
  • K220952 — MY01 Continuous Compartmental Pressure Monitor (May 24, 2022)
  • K202635 — MY01 Continuous Compartmental Pressure Monitor (December 10, 2020)
  • K193321 — MY01 Continuous Compartmental Pressure Monitor (July 30, 2020)

Other clearances for product code LXC

  • K251900 — MY01 Continuous Compartmental Pressure Monitor (January 16, 2026)
  • K242997 — MY01 Continuous Compartmental Pressure Monitor (March 13, 2025)
  • K223509 — Compremium Compartment Compressibility Monitoring System (CPM#1) (April 14, 2023)
  • K220952 — MY01 Continuous Compartmental Pressure Monitor (May 24, 2022)
  • K202635 — MY01 Continuous Compartmental Pressure Monitor (December 10, 2020)
  • K193321 — MY01 Continuous Compartmental Pressure Monitor (July 30, 2020)
  • K131966 — TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER S (February 7, 2014)
  • K090961 — TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS (June 12, 2009)
  • K060963 — TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONI (June 6, 2006)
  • K041771 — TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER (September 14, 2004)