Cleared Traditional

K822261 - LARYNGEAL MIRRORS

K822261 is an FDA 510(k) clearance for LARYNGEAL MIRRORS, manufactured by Kelleher Corp.. The device is a Class 1 Ear, Nose, Throat device with product code KAI cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K822261 · Kelleher Corp. · Ear, Nose, Throat device
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Aug 1982
Decision
32d
Days
Class 1
Risk

K822261 is an FDA 510(k) clearance for the LARYNGEAL MIRRORS. Classified as Mirror, Ent (product code KAI), Class I - General Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1982 after a review of 32 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 Kelleher Corp. devices

FDA 510(k) Submission Details - K822261

510(k) Number K822261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1982
Decision Date August 30, 1982
Days to Decision 32 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
58d faster than avg
Panel avg: 90d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

KAI Device Classification - Class 1, General Controls

Product Code KAI Mirror, 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 - KAI Mirror, Ent

All 7
Devices cleared under the same product code (KAI) and FDA review panel - the closest regulatory comparables to K822261.
ANTRUM & ATTIC MIRROR
K833601 · Microtek Medical, Inc. · Jan 1984
MIRROR TIP
K823915 · Treace Medical, Inc. · Jan 1983
BUCKINGHAM ATTIC & ANTRUM MIRROR
K822374 · Treace Medical, Inc. · Sep 1982
HEAD MIRROR WITH HEADBAND
K822191 · Kelleher Corp. · Aug 1982
ATMOS MIRROR WARMER
K820354 · Jedmed Instrument Co. · Mar 1982
MIRROR, LARYNGEAL
K770053 · Welch Allyn, Inc. · Jan 1977