Cleared Traditional

K822215 - NIC OPTRONICS CS-2000

K822215 is the FDA 510(k) clearance for NIC OPTRONICS CS-2000 by Nicolet Biomedical Instruments. It is a Class 1 Ophthalmic device (product code HOX) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K822215 · Nicolet Biomedical Instruments · Ophthalmic device
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Aug 1982
Decision
36d
Days
Class 1
Risk

K822215 is an FDA 510(k) clearance for the NIC OPTRONICS CS-2000. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by Nicolet Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on August 31, 1982 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - 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 Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K822215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1982
Decision Date August 31, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 110d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOX Chart, Visual Acuity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
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 - HOX Chart, Visual Acuity

Devices cleared under the same product code (HOX) and FDA review panel - the closest regulatory comparables to K822215.
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
K880647 · Fred Sammons, Inc. · Apr 1988
CANON AUTO ACUITOMETER CV-10
K861416 · Canon USA, Inc. · May 1986
VFS 1000/SCREENING FUNCTION ANALYZER
K830011 · CooperVision, Inc. · Jan 1983
EYE CHARTS
K813376 · Abco Dealers, Inc. · Jan 1982
BAYLOW VISUAL ACUITY TESTER
K781452 · Codman & Shurtleff, Inc. · Oct 1978