Cleared Traditional

SQUARE FOOD GUARD (K761111) - FDA 510(k) Clearance

Class I Physical Medicine device.

K761111 · Fred Sammons, Inc. · Physical Medicine device
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Dec 1976
Decision
13d
Days
Class 1
Risk

K761111 is an FDA 510(k) clearance for the SQUARE FOOD GUARD. Classified as Utensil, Eating (product code ILC), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1976 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5050 - the FDA physical medicine device framework. 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 Fred Sammons, Inc. devices

Submission Details

510(k) Number K761111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1976
Decision Date December 02, 1976
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILC Utensil, Eating
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ILC Utensil, Eating

All 27
Devices cleared under the same product code (ILC) and FDA review panel - the closest regulatory comparables to K761111.
WEIGHTED SPORK
K761105 · Fred Sammons, Inc. · Dec 1976
WEIGHTED FORK
K761106 · Fred Sammons, Inc. · Dec 1976
FOOD GUARDS
K761107 · Fred Sammons, Inc. · Dec 1976
PLASTIC HAND CONE
K761112 · Fred Sammons, Inc. · Dec 1976
BUILT-UP HANDLE UTENSILS
K761113 · Fred Sammons, Inc. · Dec 1976
CUP HOLDER/CUP, WHEELCHAIR
K760281 · Fred Sammons, Inc. · Sep 1976