Cleared Traditional

K935952 - ROTA SYSTEM 5000

K935952 is an FDA 510(k) clearance for ROTA SYSTEM 5000, manufactured by Rota Systems Medfurniture, Inc.. The device is a Class 1 Ophthalmic device with product code HMF cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K935952 · Rota Systems Medfurniture, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K935952

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.

HMF Device Classification - Class 1, General Controls

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.

Regulatory Peers - HMF Stand, Instrument, Ac-powered, Ophthalmic

Devices cleared under the same product code (HMF) and FDA review panel - the closest regulatory comparables to K935952.
BURTON OPHTHALMIC STAND - MODEL XL3200
K924771 · R.H. Burton Co. · Apr 1993
BURTON OPHTHALMIC EXAM UNIT - MODEL 2201
K924780 · R.H. Burton Co. · Apr 1993
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM
K853358 · Dentsply Intl. · Oct 1985
ELECTRIC INSTRUMENT TABLE
K832073 · CooperVision, Inc. · Aug 1983
B & L OPHTHALMIC INSTRUMENT STAND
K791104 · Bausch & Lomb, Inc. · Jul 1979
B & L OPHTHALMIC CHAIR
K791105 · Bausch & Lomb, Inc. · Jul 1979