Cleared Traditional

K854440 - MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K854440 · Keeler Instruments, Inc. · General & Plastic Surgery device
Dec 1985
Decision
41d
Days
Class 1
Risk

K854440 is an FDA 510(k) clearance for the MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50. Classified as Microscope, Operating & Accessories, Ac-powered, Ophthalmic (product code HRM), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 16, 1985 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4700 - 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.

Submission Details

510(k) Number K854440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1985
Decision Date December 16, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 132d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRM Microscope, Operating & Accessories, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4700
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.