Cleared Traditional

K843596 - NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE

K843596 is an FDA 510(k) clearance for NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE, manufactured by Nidek, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K843596 · Nidek, Inc. · Ophthalmic device
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Feb 1985
Decision
156d
Days
Class 2
Risk

K843596 is an FDA 510(k) clearance for the NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 15, 1985 after a review of 156 days - an extended review cycle.

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 Nidek, Inc. devices

FDA 510(k) Submission Details - K843596

510(k) Number K843596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1984
Decision Date February 15, 1985
Days to Decision 156 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 110d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 72
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K843596.
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP
K851263 · American Medical Optics · May 1985
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
K851264 · American Medical Optics · May 1985
AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA
K851262 · American Medical Optics · Apr 1985
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