Cleared Traditional

K772275 - TOILET SAFETY RAIL

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.

View all Med Fusion Systems, Inc. devices

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 -

Regulatory Peers - LDQ

All 19
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K772275.
PLASTIC DISPOSABLE RAZOR CAT.#1017,1018
K802003 · Pollak (Intl.), Ltd. · Sep 1980
TUBE HOLDER
K801421 · Devon Industries, Inc. · Jul 1980
CONPHAR SURGICAL RAZORR
K791798 · Conphar, Inc. · Feb 1980
CUT-DOWN BUILT-UP TOILET SEAT
K772403 · Fred Sammons, Inc. · Feb 1978
ISOLATION KIT
K770381 · American Hospital Supply Corp. · Apr 1977
RAZOR, DISPOSABLE
K760328 · Devon Industries, Inc. · Aug 1976