Cleared Traditional

RELIANCE(R) 6200 EXAMINATION CHAIR (K894018) - FDA 510(k) Clearance

Class I Ophthalmic device.

K894018 · Reliance Medical Products, Inc. · Ophthalmic device
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Sep 1989
Decision
98d
Days
Class 1
Risk

K894018 is an FDA 510(k) clearance for the RELIANCE(R) 6200 EXAMINATION CHAIR. Classified as Chair, Ophthalmic, Ac-powered (product code HME), Class I - General Controls.

Submitted by Reliance Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 12, 1989 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1140 - 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 Reliance Medical Products, Inc. devices

Submission Details

510(k) Number K894018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1989
Decision Date September 12, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HME Chair, Ophthalmic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1140
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.