Cleared Traditional

K881958 - JEDMED MAXIM ENT CABINET

K881958 is the FDA 510(k) clearance for JEDMED MAXIM ENT CABINET by Jedmed Instrument Co.. It is a Class 1 Ear, Nose, Throat device (product code ETF) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K881958 · Jedmed Instrument Co. · Ear, Nose, Throat device

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Jul 1988

Decision

66d

Days

Class 1

Risk

K881958 is an FDA 510(k) clearance for the JEDMED MAXIM ENT CABINET. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on July 15, 1988 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - the FDA ear, nose and throat 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number	K881958 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 10, 1988
Decision Date	July 15, 1988
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

23d faster than avg

Panel avg: 89d · This submission: 66d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	ETF Unit, Examining/treatment, Ent
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 874.5300

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 - ETF Unit, Examining/treatment, Ent

All 23

Devices cleared under the same product code (ETF) and FDA review panel - the closest regulatory comparables to K881958.

MOBILE TREATMENT CART

K910243 · Jedmed Instrument Co. · Apr 1991

SYSTEMA ENT CABINET

K896273 · Jedmed Instrument Co. · Jan 1990

JEDMED S CHAIR

K896298 · Jedmed Instrument Co. · Jan 1990

MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT

K860940 · Micromedics, Inc. · May 1986

LARYNGEAL MIRROR PRE-WARMER

K855021 · Jedmed Instrument Co. · Mar 1986

INSTRUMENT CABINET

K833882 · Jedmed Instrument Co. · Jan 1984

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 K881958

Jedmed Instrument Co.

St. Louis, MO · US

CRAIG RAPP

Regulatory profile

92 submissions 91 cleared

99% clearance rate · Active in Ear, Nose, Throat

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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