Cleared Traditional

K853358 - RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K853358 · Dentsply Intl. · Ophthalmic device
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Oct 1985
Decision
53d
Days
Class 1
Risk

K853358 is an FDA 510(k) clearance for the RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM. Classified as Stand, Instrument, Ac-powered, Ophthalmic (product code HMF), Class I - General Controls.

Submitted by Dentsply Intl. (Cincinnati, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 53 days - a notably fast clearance cycle.

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: 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 Dentsply Intl. devices

Submission Details

510(k) Number K853358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date October 04, 1985
Days to Decision 53 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 110d · This submission: 53d
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.