Cleared Special

K131966 - TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM

K131966 · Twin Star Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
224d
Days
-
Risk

K131966 is an FDA 510(k) clearance for the TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETE.... Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Twin Star Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on February 7, 2014 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K131966

510(k) Number K131966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2013
Decision Date February 07, 2014
Days to Decision 224 days
Submission Type Special
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
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Modification to existing cleared device.

LXC Device Classification - Class 0,

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 K131966.
MY01 Continuous Compartmental Pressure Monitor
K210525 · MY01, Inc. · Apr 2021
MY01 Continuous Compartmental Pressure Monitor
K202635 · MY01, Inc. · Dec 2020
MY01 Continuous Compartmental Pressure Monitor
K193321 · MY01, Inc. · Jul 2020
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
K090961 · Twin Star Medical, Inc. · Jun 2009
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)
K060963 · Twin Star Medical · Jun 2006
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
K041771 · Twin Star Medical, Inc. · Sep 2004
K131966 · TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
Download PDF FDA Summary Twin Star Medical, In…