Cleared Traditional

BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE (K924753) - FDA 510(k) Clearance

Class I Ophthalmic device.

K924753 · Bioenterics Corp. · Ophthalmic device
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Dec 1992
Decision
84d
Days
Class 1
Risk

K924753 is an FDA 510(k) clearance for the BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE. Classified as Screen, Tangent, Projection, Battery-powered (product code HMJ), Class I - General Controls.

Submitted by Bioenterics Corp. (Carpinteria, US). The FDA issued a Cleared decision on December 15, 1992 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1810 - 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 Bioenterics Corp. devices

Submission Details

510(k) Number K924753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1992
Decision Date December 15, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMJ Screen, Tangent, Projection, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.