Cleared Traditional

K902500 - AR-1600G AUTO-REFRACTOMETER

K902500 is an FDA 510(k) clearance for AR-1600G AUTO-REFRACTOMETER, manufactured by Nidek, Inc.. The device is a Class 1 Ophthalmic device with product code HKO cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K902500 · Nidek, Inc. · Ophthalmic device
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Jul 1990
Decision
52d
Days
Class 1
Risk

K902500 is an FDA 510(k) clearance for the AR-1600G AUTO-REFRACTOMETER. 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 27, 1990 after a review of 52 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

FDA 510(k) Submission Details - K902500

510(k) Number K902500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date July 27, 1990
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 110d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

HKO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HKO Refractometer, Ophthalmic

All 20
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K902500.
AUTOREF LENSMETER RL-10
K925304 · Canon USA, Inc. · Feb 1994
BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8
K924778 · R.H. Burton Co. · Apr 1993
BURTON AUTO REFRACTOR - MODEL BAR-7
K924790 · R.H. Burton Co. · Apr 1993
NIDEK RT-1200S (MARCO TRS-1200)
K901513 · Nidek, Inc. · Jun 1990
NIDEK AR-1200
K890559 · Nidek, Inc. · Feb 1989
CANON AUTOREFRACTOMETER R-22
K883200 · Canon USA, Inc. · Aug 1988