Cleared Traditional

K844971 - MONOCULAR DIRECT OPHTHALMOSCOPE

K844971 is the FDA 510(k) clearance for MONOCULAR DIRECT OPHTHALMOSCOPE by Nidek, Inc.. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K844971 · Nidek, Inc. · Ophthalmic device
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Feb 1985
Decision
53d
Days
Class 2
Risk

K844971 is an FDA 510(k) clearance for the MONOCULAR DIRECT 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 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nidek, Inc. devices

Submission Details

510(k) Number K844971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1984
Decision Date February 15, 1985
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
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 27
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K844971.
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
K854244 · Keeler Instruments, Inc. · Nov 1985
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
K843596 · Nidek, Inc. · Feb 1985
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
K843597 · 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