Cleared Traditional

K213037 - IDx-DR v2.3 (FDA 510(k) Clearance)

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

K213037 · Digital Diagnostics, Inc. · Ophthalmic device
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Jun 2022
Decision
269d
Days
Class 2
Risk

K213037 is an FDA 510(k) clearance for the IDx-DR v2.3. Classified as Diabetic Retinopathy Detection Device (product code PIB), Class II - Special Controls.

Submitted by Digital Diagnostics, Inc. (Coralville, US). The FDA issued a Cleared decision on June 17, 2022 after a review of 269 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1100 - 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 Digital Diagnostics, Inc. devices

Submission Details

510(k) Number K213037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2021
Decision Date June 17, 2022
Days to Decision 269 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
159d slower than avg
Panel avg: 110d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIB Diabetic Retinopathy Detection Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1100
Definition A Retinal Diagnostic Software Device Is A Prescription Software Device That Incorporates An Adaptive Algorithm To Evaluate Ophthalmic Images For Diagnostic Screening To Identify Retinal Diseases Or Conditions.
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

Hogan Lovells US LLP
Kelliann Payne

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.