Cleared Traditional

K822018 - JACKSON BITE BLOCKS

K822018 is an FDA 510(k) clearance for JACKSON BITE BLOCKS, manufactured by Kelleher Corp.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K822018 · Kelleher Corp. · Neurology device

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Aug 1982

Decision

26d

Days

Class 2

Risk

K822018 is an FDA 510(k) clearance for the JACKSON BITE BLOCKS. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1982 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - the FDA neurology 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.

FDA 510(k) Submission Details - K822018

510(k) Number	K822018 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 08, 1982
Decision Date	August 03, 1982
Days to Decision	26 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

123d faster than avg

Panel avg: 149d · This submission: 26d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

JXL Device Classification - Class 2, Special Controls

Product Code	JXL Block, Bite
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 882.5070

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXL Block, Bite

All 27

Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K822018.

DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE

K842788 · Brimms, Inc. · Sep 1984

BITESTICK BLOCK

K840789 · Cherry Plastics, Inc. · Apr 1984

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR

K830090 · Hudson Oxygen Therapy Sales Co. · Feb 1983

DENTAL MOUTH PROP.

K802696 · Trident Dental, Inc. · Nov 1980

TRI PAC MOUTH PROP

K800369 · Oxequip Health Ind. · Feb 1980

DENTAL MOUTHPROP (BITE BLOCK)

K792157 · Mission Dental, Inc. · Nov 1979

FDA 510(k) Resources - Neurology

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

Manufacturer of K822018

Kelleher Corp.

Mchenry, IL · US

Regulatory profile

94 submissions 94 cleared

100% clearance rate · Active in Neurology

View all devices by Kelleher Corp. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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 . FDA decision: August 3, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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