Cleared Traditional

K895010 - MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE

K895010 is an FDA 510(k) clearance for MENTOR SPECTACLE BINOCULAR INDIRECT OPH..., manufactured by Mentor O & O, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K895010 · Mentor O & O, Inc. · Ophthalmic device
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Sep 1989
Decision
34d
Days
Class 2
Risk

K895010 is an FDA 510(k) clearance for the MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on September 11, 1989 after a review of 34 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 Mentor O & O, Inc. devices

FDA 510(k) Submission Details - K895010

510(k) Number K895010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date September 11, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 110d · This submission: 34d
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 72
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K895010.
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
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · Keeler Instruments, Inc. · Jun 1989
VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
K893173 · Keeler Instruments, Inc. · Jun 1989
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
K854244 · Keeler Instruments, Inc. · Nov 1985