Cleared Traditional

TELL ME TAGS - NONPOWERED COMMUNICATION SYS (K844890) - FDA 510(k) Clearance

Class I Physical Medicine device.

K844890 · Mina Manufacturers, Inc. · Physical Medicine device

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Mar 1985

Decision

81d

Days

Class 1

Risk

K844890 is an FDA 510(k) clearance for the TELL ME TAGS - NONPOWERED COMMUNICATION SYS. Classified as System, Communication, Non-powered (product code ILP), Class I - General Controls.

Submitted by Mina Manufacturers, Inc. (Philadelphia, US). The FDA issued a Cleared decision on March 8, 1985 after a review of 81 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 Mina Manufacturers, Inc. devices

Submission Details

510(k) Number	K844890 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 1984
Decision Date	March 08, 1985
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

34d faster than avg

Panel avg: 115d · This submission: 81d

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 20

Devices cleared under the same product code (ILP) and FDA review panel - the closest regulatory comparables to K844890.

ADAPTIVE PENS & LAP DESK

K831546 · Fred Sammons, Inc. · Jun 1983

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

MOUTH STICK KIT

K823625 · Fred Sammons, Inc. · Dec 1982

KIT OF WORDS & LTRS TO RE-LEARN-BK4014

K823609 · 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 K844890

Mina Manufacturers, Inc.

Philadelphia, PA · US

SUSAN A MASLOW

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Physical Medicine

Data Intelligence Layer

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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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