Cleared Traditional

MOUTH STICK KIT (K823625) - FDA 510(k) Clearance

Class I Physical Medicine device.

K823625 · Fred Sammons, Inc. · Physical Medicine device

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Dec 1982

Decision

24d

Days

Class 1

Risk

K823625 is an FDA 510(k) clearance for the MOUTH STICK KIT. Classified as System, Communication, Non-powered (product code ILP), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3700 - 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	K823625 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 06, 1982
Decision Date	December 30, 1982
Days to Decision	24 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

91d faster than avg

Panel avg: 115d · This submission: 24d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	ILP System, Communication, Non-powered
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 890.3700

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 - ILP System, Communication, Non-powered

All 17

Devices cleared under the same product code (ILP) and FDA review panel - the closest regulatory comparables to K823625.

PICTURES & WORD IDENTIFICATION CVA PAT

K823608 · Fred Sammons, Inc. · Dec 1982

ADJ. WOODEN BOARD FOR WRITING

K823612 · Fred Sammons, Inc. · Dec 1982

HOLDER FOR MOUTH STICK

K823624 · Fred Sammons, Inc. · Dec 1982

KIT OF WORDS & LTRS TO RE-LEARN-BK4014

K823609 · Fred Sammons, Inc. · Dec 1982

BK-4015 ECONOMY COMMUNICATION SHEET

K823610 · Fred Sammons, Inc. · Dec 1982

PLASTIC STOP TO HOLD TELEPHONE BUTTON

K823613 · Fred Sammons, Inc. · Dec 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823625

Fred Sammons, Inc.

Walker, MI · US

Regulatory profile

278 submissions 278 cleared

100% clearance rate · Active in Physical Medicine

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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