Cleared Traditional

K200422 - Image Quality Analyzer (IQA)

K200422 is the FDA 510(k) clearance for Image Quality Analyzer (IQA) by Visionquest Biomedical, Inc.. It is a Class 2 Ophthalmic device (product code NFJ) cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K200422 · Visionquest Biomedical, Inc. · Ophthalmic device
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Dec 2020
Decision
308d
Days
Class 2
Risk

K200422 is an FDA 510(k) clearance for the Image Quality Analyzer (IQA). Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Visionquest Biomedical, Inc. (Albuquerque, US). The FDA issued a Cleared decision on December 24, 2020 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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. Elevated predicate reliance profile. 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 Visionquest Biomedical, Inc. devices

Submission Details

510(k) Number K200422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2020
Decision Date December 24, 2020
Days to Decision 308 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
198d slower than avg
Panel avg: 110d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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

Ora
Ryan Bouchard

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.

Regulatory Peers - NFJ System, Image Management, Ophthalmic

All 33
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