Cleared Traditional

K941705 - NERVE FIBER ANALYZER

K941705 is the FDA 510(k) clearance for NERVE FIBER ANALYZER by Carl Zeiss Meditec, Inc.. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K941705 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Jul 1994
Decision
103d
Days
Class 2
Risk

K941705 is an FDA 510(k) clearance for the NERVE FIBER ANALYZER. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (San Diego, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 103 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 Carl Zeiss Meditec, Inc. devices

Submission Details

510(k) Number K941705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1994
Decision Date July 18, 1994
Days to Decision 103 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 110d · This submission: 103d
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 K941705.
WELCH ALLYN VIDEO OPHTHALMOSCOPE
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WELCH ALLYN OPHTHALMOSCOPE
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KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104 · Keeler Instruments, Inc. · Aug 1994
R&D BATTERIES # 5615, 5234, 5097
K935988 · R & D Batteries, Inc. · Feb 1994
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
K930023 · Welch Allyn, Inc. · Jun 1993
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581 · Carl Zeiss, Inc. · Dec 1991