Cleared Traditional

K822259 - LARYNGEAL SPATULAS

K822259 is the FDA 510(k) clearance for LARYNGEAL SPATULAS by Kelleher Corp.. It is a Class 1 Ear, Nose, Throat device (product code EQH) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K822259 · Kelleher Corp. · Ear, Nose, Throat device

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Oct 1982

Decision

85d

Days

Class 1

Risk

K822259 is an FDA 510(k) clearance for the LARYNGEAL SPATULAS. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1982 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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

Submission Details

510(k) Number	K822259 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 1982
Decision Date	October 22, 1982
Days to Decision	85 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

4d faster than avg

Panel avg: 89d · This submission: 85d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	EQH Source, Carrier, Fiberoptic Light
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 874.4350

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 - EQH Source, Carrier, Fiberoptic Light

All 22

Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K822259.

T-TUBE INSERTER

K831590 · Treace Medical, Inc. · Jun 1983

MICROSURGICAL GAUGE

K823436 · Treace Medical, Inc. · Dec 1982

MCGEE 26GA. SUCTION TUBE

K823437 · Treace Medical, Inc. · Dec 1982

FIBEROPTIC LIGHT CARRIERS

K822282 · Kelleher Corp. · Aug 1982

ADAPTOR FOR FIBEROPTIC LIGHT SOURCE

K822175 · Kelleher Corp. · Aug 1982

FIBEROPTIC LIGHT CARRIERS

K822192 · Kelleher Corp. · Aug 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K822259

Kelleher Corp.

Mchenry, IL · US

Regulatory profile

94 submissions 94 cleared

100% clearance rate · Active in Ear, Nose, Throat

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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