Cleared Traditional

DIGITAL RETINOSCOPIC PHOTOMETER (K951179) - FDA 510(k) Clearance

Class I Ophthalmic device.

K951179 · Kudi Kalu, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
75d
Days
Class 1
Risk

K951179 is an FDA 510(k) clearance for the DIGITAL RETINOSCOPIC PHOTOMETER. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Kudi Kalu, Inc. (Huntsville, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 75 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 Kudi Kalu, Inc. devices

Submission Details

510(k) Number K951179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1995
Decision Date May 30, 1995
Days to Decision 75 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 110d · This submission: 75d
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.