Cleared Traditional

ILLUMINATED SPECULUM (K801058) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K801058 · Designs For Vision, Inc. · General & Plastic Surgery device
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May 1980
Decision
22d
Days
Class 1
Risk

K801058 is an FDA 510(k) clearance for the ILLUMINATED SPECULUM. Classified as Speculum, Illuminated (product code FXF), Class I - General Controls.

Submitted by Designs For Vision, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.1800 - the FDA general and plastic surgery 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 Designs For Vision, Inc. devices

Submission Details

510(k) Number K801058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1980
Decision Date May 28, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FXF Speculum, Illuminated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.1800
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.