Cleared Traditional

K912384 - DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE (FDA 510(k) Clearance)

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

K912384 · Nidek, Inc. · Ophthalmic device
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Dec 1991
Decision
210d
Days
Class 2
Risk

K912384 is an FDA 510(k) clearance for the DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on December 24, 1991 after a review of 210 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 Nidek, Inc. devices

Submission Details

510(k) Number K912384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date December 24, 1991
Days to Decision 210 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
100d slower than avg
Panel avg: 110d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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.