Cleared Traditional

MONOPOLAR INJECTION NEEDLE ELECTRODE (K854793) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854793 · Oculinum, Inc. · Ophthalmic device
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Feb 1986
Decision
75d
Days
Class 2
Risk

K854793 is an FDA 510(k) clearance for the MONOPOLAR INJECTION NEEDLE ELECTRODE. Classified as Preamplifier, Battery-powered, Ophthalmic (product code HLW), Class II - Special Controls.

Submitted by Oculinum, Inc. (Mill Valley, US). The FDA issued a Cleared decision on February 18, 1986 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1640 - 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 Oculinum, Inc. devices

Submission Details

510(k) Number K854793 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 05, 1985
Decision Date February 18, 1986
Days to Decision 75 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 110d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLW Preamplifier, Battery-powered, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.