Cleared Traditional

Konan Specular Microscope XVII (K191558) - FDA 510(k) Clearance

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

K191558 · Konan Medical, Inc. · Ophthalmic device
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Mar 2020
Decision
288d
Days
Class 2
Risk

K191558 is an FDA 510(k) clearance for the Konan Specular Microscope XVII. Classified as Microscope, Specular (product code NQE), Class II - Special Controls.

Submitted by Konan Medical, Inc. (Nishinomiya, JP). The FDA issued a Cleared decision on March 26, 2020 after a review of 288 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Konan Medical, Inc. devices

Submission Details

510(k) Number K191558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2019
Decision Date March 26, 2020
Days to Decision 288 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 110d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQE Microscope, Specular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
Definition Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.
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 Consultant

Matrix Medical Consulting, Inc.
Alan Donald

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.