Cleared Traditional

Vision Monitor- MonCvONE (K212936) - FDA 510(k) Clearance

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

K212936 · Metrovision · Ophthalmic device
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Nov 2022
Decision
432d
Days
Class 2
Risk

K212936 is an FDA 510(k) clearance for the Vision Monitor- MonCvONE. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Metrovision (Perenchies, FR). The FDA issued a Cleared decision on November 21, 2022 after a review of 432 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 882.1890 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Metrovision devices

Submission Details

510(k) Number K212936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2021
Decision Date November 21, 2022
Days to Decision 432 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
322d slower than avg
Panel avg: 110d · This submission: 432d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 7
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K212936.
E3 and Profile
K221471 · Diagnosys, LLC · Nov 2022
LED PHOTIC System
K211974 · Micromed S.P.A. · Sep 2021
Vision Monitor - MonpackONE
K211643 · Metrovision · Jul 2021
Nurochek System
K200705 · Cryptych Pty, Ltd. · Apr 2020
Natus Photic Stimulator
K173936 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Jun 2018
SLS 3500 LED VISUAL STIMULATOR
K842381 · Nihon Kohden America, Inc. · Nov 1984