Cleared Traditional

K812764 - KOI BLUE FIELD ENTOPTOSCOPE (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812764 · Koi, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
61d
Days
Class 2
Risk

K812764 is an FDA 510(k) clearance for the KOI BLUE FIELD ENTOPTOSCOPE. Classified as Retinoscope, Ac-powered (product code HKL), Class II - Special Controls.

Submitted by Koi, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1780 - 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 Koi, Inc. devices

Submission Details

510(k) Number K812764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1981
Decision Date December 02, 1981
Days to Decision 61 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 110d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKL Retinoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.