Cleared Traditional

K844214 - COMPARTMENT SYNDROME PRESSURE MONITOR SYS (FDA 510(k) Clearance)

K844214 · Stryker Corp. · Orthopedic device
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Apr 1985
Decision
155d
Days
-
Risk

K844214 is an FDA 510(k) clearance for the COMPARTMENT SYNDROME PRESSURE MONITOR SYS. Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on April 4, 1985 after a review of 155 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.

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Submission Details

510(k) Number K844214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1984
Decision Date April 04, 1985
Days to Decision 155 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 122d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -