Cleared Traditional

ROTA SYSTEM 5000 (K935952) - FDA 510(k) Clearance

Class I Ophthalmic device.

K935952 · Rota Systems Medfurniture, Inc. · Ophthalmic device
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Apr 1994
Decision
127d
Days
Class 1
Risk

K935952 is an FDA 510(k) clearance for the ROTA SYSTEM 5000. Classified as Stand, Instrument, Ac-powered, Ophthalmic (product code HMF), Class I - General Controls.

Submitted by Rota Systems Medfurniture, Inc. (Derby, US). The FDA issued a Cleared decision on April 19, 1994 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1860 - 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.

View all Rota Systems Medfurniture, Inc. devices

Submission Details

510(k) Number K935952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date April 19, 1994
Days to Decision 127 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
17d slower than avg
Panel avg: 110d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMF Stand, Instrument, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1860
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.