Cleared Traditional

K843304 - BINOCULAR INDIRECT OPHTHALMOSCOPE

K843304 is the FDA 510(k) clearance for BINOCULAR INDIRECT OPHTHALMOSCOPE by Mentor O & O, Inc.. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K843304 · Mentor O & O, Inc. · Ophthalmic device
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Nov 1984
Decision
90d
Days
Class 2
Risk

K843304 is an FDA 510(k) clearance for the BINOCULAR INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Mentor O & O, Inc. (Hingham, US). The FDA issued a Cleared decision on November 21, 1984 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 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 Mentor O & O, Inc. devices

Submission Details

510(k) Number K843304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1984
Decision Date November 21, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
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
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K843304.
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
K843597 · Nidek, Inc. · Feb 1985
MONOCULAR DIRECT OPHTHALMOSCOPE
K844971 · Nidek, Inc. · Feb 1985
CANON AUTO KERATOMETER K-1
K844054 · Canon USA, Inc. · Dec 1984
ALCON INDIRECT OPHTHALMOSCOPE
K822104 · Alcon Laboratories · Aug 1982
OPHTHALMOSCOPE, BINOCULAR, INDIRECT
K772214 · Varian Assoc., Inc. · Dec 1977
OPHTHALMOSCOPE, MODEL #11100
K770768 · Welch Allyn, Inc. · May 1977