Cleared Traditional

K942104 - KEELER VANTAGE INDIRECT OPHTHALMOSCOPE

K942104 is an FDA 510(k) clearance for KEELER VANTAGE INDIRECT OPHTHALMOSCOPE, manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K942104 · Keeler Instruments, Inc. · Ophthalmic device
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Aug 1994
Decision
94d
Days
Class 2
Risk

K942104 is an FDA 510(k) clearance for the KEELER VANTAGE INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on August 4, 1994 after a review of 94 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 Keeler Instruments, Inc. devices

FDA 510(k) Submission Details - K942104

510(k) Number K942104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1994
Decision Date August 04, 1994
Days to Decision 94 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 110d · This submission: 94d
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 64
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K942104.
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
K942714 · Neitz Instruments Company, Ltd. · Aug 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
K942715 · Neitz Instruments Company, Ltd. · Aug 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-12
K942720 · Neitz Instruments Company, Ltd. · Aug 1994
NERVE FIBER ANALYZER
K941705 · Carl Zeiss Meditec, Inc. · Jul 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