Cleared Traditional

HOLDER, CARD, QUAD-QUIP (K781199) - FDA 510(k) Clearance

Class I Physical Medicine device.

K781199 · Fred Sammons, Inc. · Physical Medicine device
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Jul 1978
Decision
17d
Days
Class 1
Risk

K781199 is an FDA 510(k) clearance for the HOLDER, CARD, QUAD-QUIP. Classified as Adaptor, Recreational (product code ILT), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1978 after a review of 17 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 K781199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1978
Decision Date July 31, 1978
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILT Adaptor, Recreational
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 - ILT Adaptor, Recreational

Devices cleared under the same product code (ILT) and FDA review panel - the closest regulatory comparables to K781199.
SOFT CATCHER'S MITT
K823656 · Fred Sammons, Inc. · Jan 1983
CARD HOLDER FOR QUADS
K823657 · Fred Sammons, Inc. · Jan 1983
BREATH CONTROL GAME
K761116 · Fred Sammons, Inc. · Dec 1976
VIEWER, RECLINING, BK-4089
K760288 · Fred Sammons, Inc. · Sep 1976
HOLDER, PENCIL & CRAYON, WITH STAND
K760291 · Fred Sammons, Inc. · Sep 1976
CARDS, GIANT FACE PLAYING BK-9419
K760306 · Fred Sammons, Inc. · Sep 1976