Cleared Traditional

K950091 - KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000

K950091 is an FDA 510(k) clearance for KONAN NONCON ROBO SPECULAR MICROSCOPE, manufactured by Konan Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K950091 · Konan Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
50d
Days
Class 2
Risk

K950091 is an FDA 510(k) clearance for the KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Konan Medical, Inc. (Hyogo, JP). The FDA issued a Cleared decision on March 1, 1995 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Konan Medical, Inc. devices

FDA 510(k) Submission Details - K950091

510(k) Number K950091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date March 01, 1995
Days to Decision 50 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
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 137
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K950091.
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