Cleared Traditional

K914956 - KEELER KONAN SPECULAR MICROSCOPE SP5500 (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K914956 · Keeler Instruments, Inc. · General & Plastic Surgery device
Feb 1992
Decision
90d
Days
Class 1
Risk

K914956 is an FDA 510(k) clearance for the KEELER KONAN SPECULAR MICROSCOPE SP5500. 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 February 3, 1992 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K914956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date February 03, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 132d · This submission: 90d
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.