Cleared Traditional

K912397 - PROFESSIONAL INDIRECT OPHTHALMOSCOPE

K912397 is an FDA 510(k) clearance for PROFESSIONAL INDIRECT OPHTHALMOSCOPE, manufactured by Clement Clarke, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K912397 · Clement Clarke, Inc. · Ophthalmic device
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Oct 1991
Decision
148d
Days
Class 2
Risk

K912397 is an FDA 510(k) clearance for the PROFESSIONAL INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Clement Clarke, Inc. (England, GB). The FDA issued a Cleared decision on October 23, 1991 after a review of 148 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 Clement Clarke, Inc. devices

FDA 510(k) Submission Details - K912397

510(k) Number K912397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date October 23, 1991
Days to Decision 148 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
38d slower than avg
Panel avg: 110d · This submission: 148d
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 58
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K912397.
TOPOGRAPHIC SCANNING SYSTEM TOPSS
K923742 · Carl Zeiss Meditec, Inc. · Mar 1993
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
K914484 · Hgm Medical Laser Systems, Inc. · Jan 1992
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581 · Carl Zeiss, Inc. · Dec 1991
KEELER KONAN SPECULAR MICROSCOPE SP3300
K900111 · Keeler Instruments, Inc. · Mar 1990
MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
K895010 · Mentor O & O, Inc. · Sep 1989
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · Keeler Instruments, Inc. · Jun 1989