Cleared Traditional

K791510 - BLUE FIELD ENTOPTOSCOPE BFE100

K791510 is the FDA 510(k) clearance for BLUE FIELD ENTOPTOSCOPE BFE100 by Medical Instrument Research Assoc., Inc.. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K791510 · Medical Instrument Research Assoc., Inc. · Ophthalmic device
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Dec 1979
Decision
131d
Days
Class 2
Risk

K791510 is an FDA 510(k) clearance for the BLUE FIELD ENTOPTOSCOPE BFE100. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Medical Instrument Research Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1979 after a review of 131 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 Medical Instrument Research Assoc., Inc. devices

Submission Details

510(k) Number K791510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1979
Decision Date December 11, 1979
Days to Decision 131 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 110d · This submission: 131d
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 28
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K791510.
MONOCULAR DIRECT OPHTHALMOSCOPE
K844971 · Nidek, Inc. · Feb 1985
CANON AUTO KERATOMETER K-1
K844054 · Canon USA, Inc. · Dec 1984
ALCON INDIRECT OPHTHALMOSCOPE
K822104 · Alcon Laboratories · Aug 1982
OPHTHALMOSCOPE, BINOCULAR, INDIRECT
K772214 · Varian Assoc., Inc. · Dec 1977
OPHTHALMOSCOPE, MODEL #11100
K770768 · Welch Allyn, Inc. · May 1977