Cleared Traditional

K854244 - THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE

K854244 is an FDA 510(k) clearance for THE KEELER ALL PUPIL INDIRECT OPHTHALMO..., 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 22-day FDA review.

K854244 · Keeler Instruments, Inc. · Ophthalmic device
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Nov 1985
Decision
22d
Days
Class 2
Risk

K854244 is an FDA 510(k) clearance for the THE KEELER ALL PUPIL 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 November 12, 1985 after a review of 22 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.

FDA 510(k) Submission Details - K854244

510(k) Number K854244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1985
Decision Date November 12, 1985
Days to Decision 22 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
88d faster than avg
Panel avg: 110d · This submission: 22d
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 84
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K854244.
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K882517 · Rodenstock Instrument Corp. · Jan 1989
EOL, MODEL LIO
K881984 · Eol, Inc. · Sep 1988
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K871268 · G. Rodenstock Instrumente GmbH · Jun 1987
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP
K851263 · American Medical Optics · May 1985
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
K851264 · American Medical Optics · May 1985
AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA
K851262 · American Medical Optics · Apr 1985
K854244 · THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
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