Cleared Traditional

K800756 - DUNRICH TABLES

K800756 is an FDA 510(k) clearance for DUNRICH TABLES, manufactured by Dunrich, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ETF cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K800756 · Dunrich, Inc. · Ear, Nose, Throat device
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Apr 1980
Decision
12d
Days
Class 1
Risk

K800756 is an FDA 510(k) clearance for the DUNRICH TABLES. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Dunrich, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 12 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 Dunrich, Inc. devices

FDA 510(k) Submission Details - K800756

510(k) Number K800756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1980
Decision Date April 16, 1980
Days to Decision 12 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 89d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

ETF Device Classification - Class 1, General Controls

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 24
Devices cleared under the same product code (ETF) and FDA review panel - the closest regulatory comparables to K800756.
TREATMENT UNIT FOR DOCTOR'S ROUNDS
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K801742 · Jedmed Instrument Co. · Aug 1980
ATMOS ENT TREATMENT SYSTEM SERVANT 3
K791934 · Jedmed Instrument Co. · Oct 1979
ATMOS ENT CABINET PRACTICA 3
K791935 · Jedmed Instrument Co. · Oct 1979
ATMOS ENT CABINET PRACTICA 2
K791936 · Jedmed Instrument Co. · Oct 1979