Cleared Traditional

K822268 - NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH

K822268 is an FDA 510(k) clearance for NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH, manufactured by Kelleher Corp.. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K822268 · Kelleher Corp. · Neurology device

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Jan 1983

Decision

183d

Days

Class 2

Risk

K822268 is an FDA 510(k) clearance for the NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K822268

510(k) Number	K822268 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 1982
Decision Date	January 28, 1983
Days to Decision	183 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

34d slower than avg

Panel avg: 149d · This submission: 183d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

Product Code	GWN Nystagmograph
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 882.1460

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 - GWN Nystagmograph

All 59

Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K822268.

TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL

K842886 · Teca, Inc. · Dec 1984

SERVO MED NYSTAGMOGRAPH NG-1

K843004 · Servo Med, Inc. · Oct 1984

PHILLY BOLTS

K834148 · Philadelphia Medical Specialties · Feb 1984

PHILLY BOLT ADULT PROCEDURE KIT

K823459 · Philadelphia Medical Specialties · Dec 1982

NAGASHIMA KN-52 SACCADE & PURSUIT STIM

K822266 · Kelleher Corp. · Aug 1982

PHILLY INFANT BOLT

K820151 · Philadelphia Medical Specialties · Jan 1982

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 K822268

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: January 28, 1983. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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