Cleared Traditional

HOMEMAKING UTENSILS (K810454) - FDA 510(k) Clearance

Class I Physical Medicine device.

K810454 · Fred Sammons, Inc. · Physical Medicine device
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Mar 1981
Decision
13d
Days
Class 1
Risk

K810454 is an FDA 510(k) clearance for the HOMEMAKING UTENSILS. Classified as Utensil, Homemaking (product code IKW), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 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 K810454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1981
Decision Date March 04, 1981
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 IKW Utensil, Homemaking
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 - IKW Utensil, Homemaking

All 11
Devices cleared under the same product code (IKW) and FDA review panel - the closest regulatory comparables to K810454.
TURNERS FOR KNOBS
K823633 · Fred Sammons, Inc. · Dec 1982
TINY FLEX-GLASS, SET OF 4
K821646 · Fred Sammons, Inc. · Jun 1982
JAR HOLDER & OPENER
K813631 · Fred Sammons, Inc. · Jan 1982
BK-5371 GAD-19-BOUT PERSONAL MOBIL AID
K790173 · Fred Sammons, Inc. · Feb 1979
ROLLING PIN
K761115 · Fred Sammons, Inc. · Dec 1976
PRUNING SCISSORS
K761122 · Fred Sammons, Inc. · Dec 1976