Cleared Traditional

K232273 - RM Electrode (RMH 23-01) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K232273 · Retmap, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Dec 2023
Decision
129d
Days
Class 2
Risk

K232273 is an FDA 510(k) clearance for the RM Electrode (RMH 23-01). Classified as Electrode, Corneal (product code HLZ), Class II - Special Controls.

Submitted by Retmap, Inc. (Chicago, US). The FDA issued a Cleared decision on December 7, 2023 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1220 - 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 Retmap, Inc. devices

Submission Details

510(k) Number K232273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2023
Decision Date December 07, 2023
Days to Decision 129 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
19d slower than avg
Panel avg: 110d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLZ Electrode, Corneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05509608 Enrolling by invitation Interventional Industry-sponsored

Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted Subjects

Evaluation of an Electroretinogram Sensor

90
Patients (est.)
2
Sites
Other
Purpose
Open label
Masking
Condition studied Electrode Site Reaction
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Robert Hyde, MD/PhD
Sponsor RetMap, Inc (industry)
Started 2023-03-01 → Primary completion 2025-12-31
Primary outcome
Arm1: ERG signal quality, including peak amplitudes, noise levels, and signal to noise ratios.
View full study on ClinicalTrials.gov