Cleared Traditional

TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) (K090961) - FDA 510(k) Clearance

K090961 · Twin Star Medical, Inc. · Orthopedic device
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Jun 2009
Decision
67d
Days
-
Risk

K090961 is an FDA 510(k) clearance for the TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (.... Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Twin Star Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 12, 2009 after a review of 67 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 Twin Star Medical, Inc. devices

Submission Details

510(k) Number K090961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date June 12, 2009
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -

Regulatory Peers - LXC Monitor, Pressure, Intracompartmental

All 8
Devices cleared under the same product code (LXC) and FDA review panel - the closest regulatory comparables to K090961.
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
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · Synthes (Usa) · Jul 2003