Cleared Traditional

K772276 - RAISED TOILET SEAT

K772276 · Med Fusion Systems, Inc. · General & Plastic Surgery device
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Mar 1978
Decision
95d
Days
-
Risk

K772276 is an FDA 510(k) clearance for the RAISED TOILET SEAT.

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

FDA 510(k) Submission Details - K772276

510(k) Number K772276 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.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 39
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K772276.
TUBE HOLDER
K801421 · Devon Industries, Inc. · Jul 1980
CONPHAR SURGICAL RAZORR
K791798 · Conphar, Inc. · Feb 1980
TOILET SAFETY RAIL
K772275 · Med Fusion Systems, Inc. · Mar 1978
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