Cleared Traditional

K791510 - BLUE FIELD ENTOPTOSCOPE BFE100

K791510 is an FDA 510(k) clearance for BLUE FIELD ENTOPTOSCOPE BFE100, manufactured by Medical Instrument Research Assoc., Inc.. The device is a Class 2 Ophthalmic device with 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.

FDA 510(k) Submission Details - K791510

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
Combination Product No
PCCP Authorized No
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.

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 86
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K791510.
WOODLYN CLASSIC KERATOMETER
K841767 · Woodlyn, Inc. · Aug 1984
WOODLYN SLIT LAMP HSSL-EC
K841763 · Woodlyn, Inc. · Aug 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
K791510 · BLUE FIELD ENTOPTOSCOPE BFE100
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