Cleared Abbreviated

K141638 - PROPPER INSIGHT BINOCULAR INDIRECT OPHT...

K141638 is an FDA 510(k) clearance for PROPPER INSIGHT BINOCULAR INDIRECT OPHT..., manufactured by Propper Manufacturing Co., Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K141638 · Propper Manufacturing Co., Inc. · Ophthalmic device
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Sep 2014
Decision
90d
Days
Class 2
Risk

K141638 is an FDA 510(k) clearance for the PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on September 17, 2014 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Propper Manufacturing Co., Inc. devices

FDA 510(k) Submission Details - K141638

510(k) Number K141638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2014
Decision Date September 17, 2014
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLI Ophthalmoscope, Ac-powered

All 35
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