Cleared Traditional

K882191 - NIDEK ARK-2000 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K882191 · Nidek, Inc. · Ophthalmic device
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Jul 1988
Decision
38d
Days
Class 1
Risk

K882191 is an FDA 510(k) clearance for the NIDEK ARK-2000. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - the FDA ophthalmic 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 Nidek, Inc. devices

Submission Details

510(k) Number K882191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date July 01, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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.