Cleared Traditional

K822266 - NAGASHIMA KN-52 SACCADE & PURSUIT STIM

K822266 is the FDA 510(k) clearance for NAGASHIMA KN-52 SACCADE & PURSUIT STIM by Kelleher Corp.. It is a Class 2 Neurology device (product code GWN) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K822266 · Kelleher Corp. · Neurology device
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Aug 1982
Decision
18d
Days
Class 2
Risk

K822266 is an FDA 510(k) clearance for the NAGASHIMA KN-52 SACCADE & PURSUIT STIM. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 18 days - a notably fast clearance 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: 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 K822266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1982
Decision Date August 16, 1982
Days to Decision 18 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
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.