Cleared Traditional

TOILET SAFETY RAIL (K772275) - FDA 510(k) Clearance

K772275 · Med Fusion Systems, Inc. · General & Plastic Surgery device
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Mar 1978
Decision
95d
Days
-
Risk

K772275 is an FDA 510(k) clearance for the TOILET SAFETY RAIL.

Submitted by Med Fusion Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 14, 1978 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K772275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1977
Decision Date March 14, 1978
Days to Decision 95 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -