Cleared Traditional

QUADRIPLEGIC MEAT KNIFE (K771274) - FDA 510(k) Clearance

Class I Physical Medicine device.

K771274 · Fred Sammons, Inc. · Physical Medicine device
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Jul 1977
Decision
38d
Days
Class 1
Risk

K771274 is an FDA 510(k) clearance for the QUADRIPLEGIC MEAT KNIFE. 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 July 21, 1977 after a review of 38 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 K771274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1977
Decision Date July 21, 1977
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 K771274.
KNIFE, ROCKER, SLOTTED HANDLE
K781192 · Fred Sammons, Inc. · Jul 1978
KNIFE, LARGE HANDLE
K781193 · Fred Sammons, Inc. · Jul 1978
UTENSILS, WEIGHTED
K781196 · Fred Sammons, Inc. · Jul 1978
ADULT SWIVEL FORK
K761104 · Fred Sammons, Inc. · Dec 1976
WEIGHTED SPORK
K761105 · Fred Sammons, Inc. · Dec 1976
WEIGHTED FORK
K761106 · Fred Sammons, Inc. · Dec 1976