Cleared Traditional

K951338 - INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO...

K951338 is an FDA 510(k) clearance for INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO..., manufactured by Neitz Instruments Company, Ltd.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K951338 · Neitz Instruments Company, Ltd. · Ophthalmic device
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Apr 1995
Decision
14d
Days
Class 2
Risk

K951338 is an FDA 510(k) clearance for the INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on April 7, 1995 after a review of 14 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 Neitz Instruments Company, Ltd. devices

FDA 510(k) Submission Details - K951338

510(k) Number K951338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1995
Decision Date April 07, 1995
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
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 28
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K951338.
HUMPHREY OCT SCANNER
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K951132 · Carl Zeiss Meditec, Inc. · Jun 1995
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210 · Welch Allyn, Inc. · Jun 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461 · Welch Allyn, Inc. · Apr 1995
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104 · Keeler Instruments, Inc. · Aug 1994
NERVE FIBER ANALYZER
K941705 · Carl Zeiss Meditec, Inc. · Jul 1994