Cleared Traditional

K802958 - AUTO REFRACTOMETER NR-1000

K802958 is an FDA 510(k) clearance for AUTO REFRACTOMETER NR-1000, manufactured by Nippon Kogaku, Inc.. The device is a Class 1 Chemistry device with product code HKO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K802958 · Nippon Kogaku, Inc. · Chemistry device
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Apr 1981
Decision
154d
Days
Class 1
Risk

K802958 is an FDA 510(k) clearance for the AUTO REFRACTOMETER NR-1000. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Nippon Kogaku, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 886.1760 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Nippon Kogaku, Inc. devices

FDA 510(k) Submission Details - K802958

510(k) Number K802958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1980
Decision Date April 23, 1981
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 88d · This submission: 154d
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 22
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K802958.
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
AUTOREFRACTOR, SUBJECTIVE
K781014 · Cavitron Corp. · Sep 1978
SUBJECTIVE REFRACTOR, MOSEL SR-111
K771914 · American Optical Corp. · Nov 1977