Cleared Traditional

RELIANCE 5000 (K853151) - FDA 510(k) Clearance

Class I Ophthalmic device.

K853151 · F. & F. Koenigkramer · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
38d
Days
Class 1
Risk

K853151 is an FDA 510(k) clearance for the RELIANCE 5000. Classified as Chair, Ophthalmic, Ac-powered (product code HME), Class I - General Controls.

Submitted by F. & F. Koenigkramer (Cincinnati, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all F. & F. Koenigkramer devices

Submission Details

510(k) Number K853151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1985
Decision Date September 05, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
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.