Cleared Traditional

K851794 - 41-180 TO 41-246 VARIOUS NASAL FORCEPS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K851794 · Artiberia · Ear, Nose, Throat device
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Jun 1985
Decision
47d
Days
Class 1
Risk

K851794 is an FDA 510(k) clearance for the 41-180 TO 41-246 VARIOUS NASAL FORCEPS. Classified as Forceps, Ent (product code KAE), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 11, 1985 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 Artiberia devices

Submission Details

510(k) Number K851794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date June 11, 1985
Days to Decision 47 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
42d faster than avg
Panel avg: 89d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAE Forceps, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.