Cleared Traditional

K812895 - YARMO NASAL CARTILAGE SOFTENER

K812895 is an FDA 510(k) clearance for YARMO NASAL CARTILAGE SOFTENER, manufactured by American V. Mueller. The device is a Class 1 Ear, Nose, Throat device with product code KAE cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812895 · American V. Mueller · Ear, Nose, Throat device
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Nov 1981
Decision
18d
Days
Class 1
Risk

K812895 is an FDA 510(k) clearance for the YARMO NASAL CARTILAGE SOFTENER. Classified as Forceps, Ent (product code KAE), Class I - General Controls.

Submitted by American V. Mueller (Mchenry, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 18 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 American V. Mueller devices

FDA 510(k) Submission Details - K812895

510(k) Number K812895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1981
Decision Date November 02, 1981
Days to Decision 18 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
72d faster than avg
Panel avg: 90d · This submission: 18d
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 K812895.
MCGEE FORCEPS
K833607 · Microtek Medical, Inc. · Jan 1984
MICRO & MINI-MICRO ALLIGATOR FORCEPS
K822369 · Treace Medical, Inc. · Sep 1982
OFFICE ECONO-FORCEPS
K822372 · Treace Medical, Inc. · Sep 1982
HILDYARD POST NASAL FORCEP
K772377 · Edward Weck, Inc. · Jan 1978
ALLIGATOR CUP FORCEPS
K772396 · Edward Weck, Inc. · Jan 1978
COTTLE COLUMELLA FORCEP
K772397 · Edward Weck, Inc. · Jan 1978