Not Cleared Direct

DEN130051 - PEDIATRIC VISION SCANNER (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN130051 · Rebiscan, Inc. · Ophthalmic device
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Jun 2016
Decision
908d
Days
Class 2
Risk

DEN130051 is an FDA 510(k) submission (not cleared) for the PEDIATRIC VISION SCANNER. Classified as Strabismus Detection Device (product code PMW), Class II - Special Controls.

Submitted by Rebiscan, Inc. (Cambridge, US). The FDA issued a Not Cleared (DENG) decision on June 8, 2016 after a review of 908 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1342 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 908 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Rebiscan, Inc. devices

Submission Details

510(k) Number DEN130051 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 13, 2013
Decision Date June 08, 2016
Days to Decision 908 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
798d slower than avg
Panel avg: 110d · This submission: 908d
Pathway characteristics

Device Classification

Product Code PMW Strabismus Detection Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1342
Definition For The Automated Detection Of Misalignment Of The Visual Axes For Prescription Use Only.
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.