Cleared Traditional

K760281 - CUP HOLDER/CUP

K760281 is the FDA 510(k) clearance for CUP HOLDER/CUP by Fred Sammons, Inc.. It is a Class 1 Physical Medicine device (product code ILC) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K760281 · Fred Sammons, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1976
Decision
47d
Days
Class 1
Risk

K760281 is an FDA 510(k) clearance for the CUP HOLDER/CUP, WHEELCHAIR. 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 September 8, 1976 after a review of 47 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 K760281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1976
Decision Date September 08, 1976
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
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 28
Devices cleared under the same product code (ILC) and FDA review panel - the closest regulatory comparables to K760281.
SQUARE FOOD GUARD
K761111 · 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,BK-1140
K760282 · Fred Sammons, Inc. · Sep 1976
GLASS, SIP N' STRAW WITH LID, 1143
K760283 · Fred Sammons, Inc. · Sep 1976
GLASS, NOSEY CUTOUT, BK-1146
K760284 · Fred Sammons, Inc. · Sep 1976