Cleared Traditional

K041771 - TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM (FDA 510(k) Clearance)

K041771 · Twin Star Medical, Inc. · Orthopedic device
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Sep 2004
Decision
76d
Days
-
Risk

K041771 is an FDA 510(k) clearance for the TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHE.... Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Twin Star Medical, Inc. (Washington, US). The FDA issued a Cleared decision on September 14, 2004 after a review of 76 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 K041771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2004
Decision Date September 14, 2004
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -