Cleared Traditional

K930023 - MODEL #12000 BINOCULAR INDERECT OPHTHAL...

K930023 is the FDA 510(k) clearance for MODEL #12000 BINOCULAR INDERECT OPHTHAL... by Welch Allyn, Inc.. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K930023 · Welch Allyn, Inc. · Ophthalmic device
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Jun 1993
Decision
167d
Days
Class 2
Risk

K930023 is an FDA 510(k) clearance for the MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 21, 1993 after a review of 167 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K930023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date June 21, 1993
Days to Decision 167 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 110d · This submission: 167d
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 20
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K930023.
WELCH ALLYN OPHTHALMOSCOPE
K950461 · Welch Allyn, Inc. · Apr 1995
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104 · Keeler Instruments, Inc. · Aug 1994
R&D BATTERIES # 5615, 5234, 5097
K935988 · R & D Batteries, Inc. · Feb 1994
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581 · Carl Zeiss, Inc. · Dec 1991
KEELER KONAN SPECULAR MICROSCOPE SP3300
K900111 · Keeler Instruments, Inc. · Mar 1990
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · Keeler Instruments, Inc. · Jun 1989