Cleared Traditional

K851775 - 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS

K851775 is an FDA 510(k) clearance for 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS, manufactured by Artiberia. The device is a Class 1 Ear, Nose, Throat device with product code KAE cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K851775 · Artiberia · Ear, Nose, Throat device
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Jun 1985
Decision
47d
Days
Class 1
Risk

K851775 is an FDA 510(k) clearance for the 19-790 TO 19-1042 DRESSING/SPONGE 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

FDA 510(k) Submission Details - K851775

510(k) Number K851775 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 89d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

KAE Device Classification - Class 1, General Controls

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.

Regulatory Peers - KAE Forceps, Ent

All 13
Devices cleared under the same product code (KAE) and FDA review panel - the closest regulatory comparables to K851775.
LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE
K853708 · Downs Surgical , Ltd. · Feb 1986
41-180 TO 41-246 VARIOUS NASAL FORCEPS
K851794 · Artiberia · Jun 1985
41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS
K851795 · Artiberia · Jun 1985
GOLD ALLIGATOR FORCEPS
K833608 · Microtek Medical, Inc. · Jan 1984
CUPPED FORCEPS
K833605 · Microtek Medical, Inc. · Jan 1984
MCGEE FORCEPS
K833607 · Microtek Medical, Inc. · Jan 1984