Cleared Traditional

K831083 - AUTO REFRACTOMETER

K831083 is the FDA 510(k) clearance for AUTO REFRACTOMETER by Nidek, Inc.. It is a Class 1 Ophthalmic device (product code HKO) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K831083 · Nidek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
67d
Days
Class 1
Risk

K831083 is an FDA 510(k) clearance for the AUTO REFRACTOMETER. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Nidek, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 10, 1983 after a review of 67 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 K831083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date June 10, 1983
Days to Decision 67 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
43d faster than avg
Panel avg: 110d · This submission: 67d
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.

Regulatory Peers - HKO Refractometer, Ophthalmic

All 18
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K831083.
AR-1600 AUTOMATIC REFRACTOR
K861062 · Nidek, Inc. · Apr 1986
AR-1000 AUTOMATIC REFRACTOR
K861066 · Nidek, Inc. · Apr 1986
CANON AUTOREF R-10
K841861 · Canon USA, Inc. · Oct 1984
I.V.E. REFRACTION SYSTEM
K812896 · Bausch & Lomb, Inc. · Dec 1981
SR-1V DATA PRINTER
K812063 · American Optical Corp. · Aug 1981
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR
K802183 · American Optical Corp. · Apr 1981